Richard Pazdur

Affiliations
  • Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Publications (99)

FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib.

The oncologist
Avec: May Tun Saung , Lorraine Pelosof , Sandra Casak , Martha Donoghue , Steven Lemery , Mengdie Yuan , Lisa Rodriguez , Peter Schotland , Meredith Chuk , Gina Davis , Kirsten B Goldberg , Marc R Theoret , Lola Fashoyin-Aje

FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA-Mutated Metastatic Castrate-Resistant Prostate Cancer.

The oncologist
Avec: Mitchell S Anscher , Elaine Chang , Xin Gao , Yutao Gong , Chana Weinstock , Erik Bloomquist , Oluseyi Adeniyi , Rosane Charlab , Sarah Zimmerman , Maritsa Serlemitsos-Day , Yang Min Ning , Ruth Mayrosh , Barbara Fuller , Ann Marie Trentacosti , Pamela Gallagher , Karen Bijwaard , Reena Philip , Soma Ghosh , Frances Fahnbulleh , Felicia Diggs , Shaily Arora , Kirsten B Goldberg , Shenghui Tang , Laleh Amiri-Kordestani , Amna Ibrahim , Julia A Beaver

FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non-small Cell Lung Cancer, A Collaborative Project Orbis Review.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Paz J Vellanki , Flora Mulkey , Adnan A Jaigirdar , Lisa Rodriguez , Yibo Wang , Yuan Xu , Hong Zhao , Jiang Liu , Grant Howe , Jian Wang , Qiuyi Choo , Sarah J Golding , Victoria Mansell , Kwadwo Korsah , Dianne Spillman , R Angelo de Claro , Julia A Beaver , Harpreet Singh

FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Jennifer J Gao , Christy L Osgood , Yutao Gong , Hui Zhang , Erik W Bloomquist , Xiling Jiang , Junshan Qiu , Jingyu Yu , Pengfei Song , Nam Atiqur Rahman , Haw-Jyh Chiu , Tiffany K Ricks , Fatima Rizvi , Sherry Hou , Willie Wilson , Abde M Abukhdeir , Jeffrey Seidman , Soma Ghosh , Reena Philip , William F Pierce , Vishal Bhatnagar , Paul G Kluetz , Julia A Beaver , Laleh Amiri-Kordestani

Benefit-Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy.

The oncologist
Avec: Lorraine Pelosof , May Tun Saung , Martha Donoghue , Sandra Casak , Sirisha Mushti , Joyce Cheng , Xiling Jiang , Jiang Liu , Hong Zhao , Maryam Khazraee , Kirsten B Goldberg , Marc Theoret , Steven Lemery , Lola Fashoyin-Aje

Global Variation in Opioid Use in Prostate Cancer Trials.

JAMA oncology
Avec: Jessica K Roydhouse , Daniel L Suzman , Laurel A Menapace , Pallavi S Mishra-Kalyani , Rajeshwari Sridhara , Gideon M Blumenthal , Julia A Beaver , Paul G Kluetz

FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Lynn J Howie , Nancy S Scher , Laleh Amiri-Kordestani , Lijun Zhang , Bellinda L King-Kallimanis , Yasmin Choudhry , Jason Schroeder , Kirsten B Goldberg , Paul G Kluetz , Amna Ibrahim , Rajeshwari Sridhara , Gideon M Blumenthal , Julia A Beaver

Comparison of iRECIST versus RECIST V.1.1 in patients treated with an anti-PD-1 or PD-L1 antibody: pooled FDA analysis.

Journal for immunotherapy of cancer
Avec: Flora Mulkey , Marc R Theoret , Patricia Keegan , Rajeshwari Sridhara

Oncology Expanded Access and FDA's Project Facilitate.

The oncologist
Avec: Barbara Scepura , Mitchell Chan , Tamy Kim , Jessica Boehmer , Kirsten B Goldberg ,

Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop.

Nature reviews. Urology
Avec: Elaine Chang , Andrea B Apolo , Rick Bangs , Stephanie Chisolm , Vinay Duddalwar , Jason A Efstathiou , Kirsten B Goldberg , Donna E Hansel , Ashish M Kamat , Paul G Kluetz , Seth P Lerner , Elizabeth Plimack , Tatiana Prowell , Harpreet Singh , Daniel Suzman , Evan Y Yu , Hui Zhang , Julia A Beaver , Chana Weinstock , Matthew D Galsky

FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non-Small Cell Lung Cancer, a Collaborative Project Orbis Review.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Abigail L Koch , Paz J Vellanki , Nicole Drezner , Xiaoxue Li , Pallavi S Mishra-Kalyani , Yuan Li Shen , Huiming Xia , Yangbing Li , Jiang Liu , Jeanne Fourie Zirkelbach , Elitza Palazov , Aleksandr Gamarian , Qiuyi Choo , Arūnas Girčys , Ulrich-Peter Rohr , Nataliya Fesenko , Dianne Spillman , Julia A Beaver , Harpreet Singh

External control arms in oncology: current use and future directions.

Annals of oncology : official journal of the European Society for Medical Oncology
Avec: P S Mishra-Kalyani , L Amiri Kordestani , D R Rivera , H Singh , A Ibrahim , R A DeClaro , Y Shen , S Tang , R Sridhara , P G Kluetz , J Concato , R Pazdur , J A Beaver

U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Shaily Arora , Preeti Narayan , Gwynn Ison , Tara Berman , Daniel L Suzman , Suparna Wedam , Tatiana M Prowell , Soma Ghosh , Reena Philip , Christy L Osgood , Jennifer J Gao , Mirat Shah , Danielle Krol , Sakar Wahby , Melanie Royce , Christina Brus , Erik W Bloomquist , Mallorie H Fiero , Shenghui Tang , Amna Ibrahim , Laleh Amiri-Kordestani , Julia A Beaver

Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials.

Blood advances
Avec: Bindu Kanapuru , Laura L Fernandes , Lola A Fashoyin-Aje , Andrea C Baines , Vishal Bhatnagar , Rachel Ershler , Thomas Gwise , Paul Kluetz , Elizabeth Pulte , Yuan-Li Shen , Nicole Gormley

FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy.

The oncologist
Avec: Robert Q Le , Xin Wang , Hongfei Zhang , Hongshan Li , Donna Przepiorka , Jonathon Vallejo , Ruby Leong , Lian Ma , Kirsten B Goldberg , Marc R Theoret , Angelo De Claro

FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Andrea C Baines , Rachel Ershler , Bindu Kanapuru , Qing Xu , Guoxiang Shen , Liang Li , Lian Ma , Olanrewaju O Okusanya , Natalie E Simpson , Wanda Nguyen , Marc R Theoret , Nicole J Gormley

FDA Approval Summary: Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Nina Kim , Kelly J Norsworthy , Sriram Subramaniam , Haiyan Chen , Michael L Manning , Eliford Kitabi , Justin Earp , Lori A Ehrlich , Olanrewaju O Okusanya , Jonathon Vallejo , Brenda J Gehrke , R Angelo de Claro ,

US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Avec: Brian L Heiss , Elaine Chang , Xin Gao , Tien Truong , Michael H Brave , Erik Bloomquist , Ankit Shah , Salaheldin Hamed , Jeffrey Kraft , Haw-Jyh Chiu , Tiffany K Ricks , Amy Tilley , William F Pierce , Liuya Tang , Abdelrahmman Abukhdeir , Shyam Kalavar , Reena Philip , Shenghui Tang , Laleh Amiri-Kordestani , Paul G Kluetz , Daniel L Suzman

FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Donna Przepiorka , Robert Q Le , Alexei Ionan , Ruo-Jing Li , Ying-Hong Wang , Ramadevi Gudi , Soumya Mitra , Jonathon Vallejo , Olanrewaju O Okusanya , Lian Ma , Yuching Yang , Paresma Patel , Djelila Mezaache , Rakhi Shah , Anamitro Banerjee , Sherita McLamore , Adam N Maung , Kirsten B Goldberg , Marc R Theoret , R Angelo De Claro

FDA Approval Summary: Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Michael H Brave , William F Maguire , Chana Weinstock , Hui Zhang , Xin Gao , Fang Li , Jingyu Yu , Wentao Fu , Hong Zhao , William F Pierce , Elaine Chang , Jeannette Dinin , Mallorie H Fiero , Nam Atiqur Rahman , Shenghui Tang , Paul G Kluetz , Laleh Amiri-Kordestani , Daniel L Suzman

FDA Approval Summary: Atezolizumab as Adjuvant Treatment following Surgical Resection and Platinum-Based Chemotherapy for Stage II to IIIA NSCLC.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Luckson N Mathieu , Erin Larkins , Arup K Sinha , Pallavi S Mishra-Kalyani , Samina Jafri , Shyam Kalavar , Soma Ghosh , Kirsten B Goldberg , Julia A Beaver , Harpreet Singh

Driving Diversity and Inclusion in Cancer Drug Development - Industry and Regulatory Perspectives, Current Practices, Opportunities, and Challenges.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Lola A Fashoyin-Aje , Craig Tendler , Bea Lavery , Serban Ghiorghiu , Brittany Gerald , Chitkala Kalidas , Nicole Richie , Kathleen Winson , Nicholas J H Warren , Tristen V Tellman , Jon Retzlaff , Margaret Foti ,

FDA Approval Summary: Dabrafenib in combination with trametinib for BRAF V600E mutation-positive low-grade glioma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Michael I Barbato , Jeannette Nashed , Diana Bradford , Yi Ren , Sachia Khasar , Claudia P Miller , Banu S Zolnik , Hong Zhao , Yangbing Li , Youwei Bi , Stacy S Shord , Anup K Amatya , Pallavi S Mishra-Kalyani , Barbara Scepura , Raniya A Al-Matari , Paul G Kluetz , Martha Donoghue , Harpreet Singh , Nicole Drezner

FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Yvette L Kasamon , Haiyan Chen , R Angelo de Claro , Lei Nie , Jingjing Ye , Gideon M Blumenthal , Ann T Farrell ,

FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Suparna Wedam , Lola Fashoyin-Aje , Erik Bloomquist , Shenghui Tang , Rajeshwari Sridhara , Kirsten B Goldberg , Marc R Theoret , Laleh Amiri-Kordestani , Julia A Beaver

FDA Approval Summary: Pembrolizumab for the Treatment of Microsatellite Instability-High Solid Tumors.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Leigh Marcus , Steven J Lemery , Patricia Keegan ,

Analysis of time-to-treatment discontinuation of targeted therapy, immunotherapy, and chemotherapy in clinical trials of patients with non-small-cell lung cancer.

Annals of oncology : official journal of the European Society for Medical Oncology
Avec: G M Blumenthal , Y Gong , K Kehl , P Mishra-Kalyani , K B Goldberg , S Khozin , P G Kluetz , G R Oxnard , R Pazdur

FDA Approval Summary: Calaspargase Pegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Ruo-Jing Li , Runyan Jin , Chao Liu , Xianhua Cao , Michael L Manning , Xu Michael Di , Donna Przepiorka , Frances Namuswe , Albert Deisseroth , Kirsten B Goldberg , Gideon M Blumenthal ,

FDA Approval Summary: Axicabtagene Ciloleucel for Relapsed or Refractory Large B-cell Lymphoma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Najat Bouchkouj , Yvette L Kasamon , R Angelo de Claro , Bindu George , Xue Lin , Shiowjen Lee , Gideon M Blumenthal , Wilson Bryan , Amy E McKee ,

FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Emily Y Jen , Qing Xu , Aaron Schetter , Donna Przepiorka , Yuan Li Shen , Donna Roscoe , Rajeshwari Sridhara , Albert Deisseroth , Reena Philip , Ann T Farrell ,

FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.

The oncologist
Avec: Daniel L Suzman , Sundeep Agrawal , Yang-Min Ning , V Ellen Maher , Laura L Fernandes , Stella Karuri , Shenghui Tang , Rajeshwari Sridhara , Jason Schroeder , Kirsten B Goldberg , Amna Ibrahim , Amy E McKee , Julia A Beaver

FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1.

The oncologist
Avec: Lola Fashoyin-Aje , Martha Donoghue , Huanyu Chen , Kun He , Janaki Veeraraghavan , Kirsten B Goldberg , Patricia Keegan , Amy E McKee ,

Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.

Journal of the National Cancer Institute
Avec: Jiaxi Zhou , Jonathon Vallejo , Paul Kluetz , Tamy Kim , Patricia Keegan , Ann Farrell , Julia A Beaver , Rajeshwari Sridhara

FDA Approval Summary: Atezolizumab and Durvalumab in Combination with Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer.

The oncologist
Avec: Luckson Mathieu , Sujay Shah , Lee Pai-Scherf , Erin Larkins , Jonathon Vallejo , Xiaoxue Li , Lisa Rodriguez , Pallavi Mishra-Kalyani , Kirsten B Goldberg , Paul G Kluetz , Marc R Theoret , Julia A Beaver , Harpreet Singh

FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Sonia Singh , Adnan A Jaigirdar , Flora Mulkey , Joyce Cheng , Salaheldin S Hamed , Yangbing Li , Jiang Liu , Hong Zhao , Anwar Goheer , Whitney S Helms , Xing Wang , Rajiv Agarwal , Rajan Pragani , Kwadwo Korsah , Shenghui Tang , John Leighton , Atiqur Rahman , Julia A Beaver , Marc R Theoret , Harpreet Singh

Project Orbis: Global Collaborative Review Program.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: R Angelo de Claro , Dianne Spillman , Lauren Tesh Hotaki , Michael Shum , Laila Sofia Mouawad , Gustavo Mendes Lima Santos , Kelly Robinson , Melissa Hunt , Caroline Healy , Agnes Chan , Yee Hoo Looi , Clare Rodrigues , Ulrich-Peter Rohr , Chantal Walther ,

FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Mirat Shah , Suparna Wedam , Joyce Cheng , Mallorie H Fiero , Huiming Xia , Fang Li , Jianghong Fan , Xinyuan Zhang , Jingyu Yu , Pengfei Song , Wei Chen , Tiffany K Ricks , Xiao Hong Chen , Kirsten B Goldberg , Yutao Gong , William F Pierce , Shenghui Tang , Marc R Theoret , Laleh Amiri-Kordestani , Julia A Beaver

FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Sandra J Casak , Leigh Marcus , Lola Fashoyin-Aje , Sirisha L Mushti , Joyce Cheng , Yuan-Li Shen , William F Pierce , Leah Her , Kirsten B Goldberg , Marc R Theoret , Paul G Kluetz , Steven J Lemery

Overall survival in patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer treated with a cyclin-dependent kinase 4/6 inhibitor plus fulvestrant: a US Food and Drug Administration pooled analysis.

The Lancet. Oncology
Avec: Jennifer J Gao , Joyce Cheng , Tatiana M Prowell , Erik Bloomquist , Shenghui Tang , Suparna B Wedam , Melanie Royce , Danielle Krol , Christy Osgood , Gwynn Ison , Rajeshwari Sridhara , Julia A Beaver , Laleh Amiri-Kordestani

U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Shaily Arora , Preeti Narayan , Christy L Osgood , Suparna Wedam , Tatiana M Prowell , Jennifer J Gao , Mirat Shah , Danielle Krol , Sakar Wahby , Melanie Royce , Soma Ghosh , Reena Philip , Gwynn Ison , Tara Berman , Christina Brus , Erik W Bloomquist , Mallorie H Fiero , Shenghui Tang , Amna Ibrahim , Laleh Amiri-Kordestani , Julia A Beaver

Perspectives on Drug Development in Multiple Myeloma-Looking Forward to 2025.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Peter M Voorhees , Andrzej J Jakubowiak , Shaji K Kumar , Bindu Kanapuru , Andrea C Baines , Vishal Bhatnagar , Rachel Ershler , Marc R Theoret , Nicole J Gormley ,

FDA Approval Summary: Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Poornima Sharma , Bindu Kanapuru , Bindu George , Xue Lin , Zhenzhen Xu , Wilson W Bryan , Marc R Theoret

FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Timil H Patel , Leigh Marcus , M Naomi Horiba , Martha Donoghue , Somak Chatterjee , Pallavi S Mishra-Kalyani , Robert N Schuck , Yangbing Li , Xinyuan Zhang , Jeanne Fourie Zirkelbach , Rosane Charlab , Jiang Liu , Yuching Yang , Steven J Lemery , Marc R Theoret , Lola A Fashoyin-Aje

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Asma Dilawari , Mirat Shah , Gwynn Ison , Haley Gittleman , Mallorie H Fiero , Ankit Shah , Salaheldin S Hamed , Junshan Qiu , Jingyu Yu , Wimolnut Manheng , Tiffany K Ricks , Rajan Pragani , Arulvathani Arudchandran , Paresma Patel , Shadia Zaman , Arpita Roy , Shyam Kalavar , Soma Ghosh , William F Pierce , Nam Atiqur Rahman , Shenghui Tang , Bronwyn D Mixter , Paul G Kluetz , Laleh Amiri-Kordestani

Eligibility criteria and enrollment of a diverse racial and ethnic population in multiple myeloma clinical trials.

Blood
Avec: Bindu Kanapuru , Laura L Fernandes , Andrea Baines , Rachel Ershler , Vishal Bhatnagar , Elizabeth Pulte , Thomas Gwise , Marc R Theoret , Lola Fashoyin-Aje , Nicole Gormley

Minimal Residual Disease Data in Hematologic Malignancy Drug Applications and Labeling: An FDA Perspective.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Andrea C Baines , Maryam Sarraf Yazdy , Yvette L Kasamon , Rachel Ershler , Emily Y Jen , Bindu Kanapuru , Nicholas C Richardson , Ashley Lane , Theresa Carioti , Marc R Theoret , Nicole J Gormley

FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Jennifer J Gao , Christy L Osgood , Zhou Feng , Erik W Bloomquist , Shenghui Tang , C J George Chang , Tiffany K Ricks , Sherry C Hou , William F Pierce , Donna R Rivera , Paul G Kluetz , Laleh Amiri-Kordestani

FDA Approval Summary: Tremelimumab in combination with durvalumab for the treatment of patients with unresectable hepatocellular carcinoma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Timil H Patel , Jamie R Brewer , Jiaxin Fan , Joyce Cheng , Yuan Li Shen , Yue Xiang , Hong Zhao , Steven J Lemery , Paul G Kluetz , Lola A Fashoyin-Aje

Efficacy of Poly(ADP-ribose) Polymerase Inhibitors by Individual Genes in Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer: A US Food and Drug Administration Pooled Analysis.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Avec: Jaleh Fallah , Jianjin Xu , Chana Weinstock , Xin Gao , Brian L Heiss , William F Maguire , Elaine Chang , Sundeep Agrawal , Shenghui Tang , Laleh Amiri-Kordestani , Paul G Kluetz , Daniel L Suzman

US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative,

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Avec: Mirat Shah , Hima Lingam , Xin Gao , Haley Gittleman , Mallorie H Fiero , Danielle Krol , Nikolett Biel , Tiffany K Ricks , Wentao Fu , Salaheldin Hamed , Fang Li , Jillian Jielin Sun , Jianghong Fan , Robert Schuck , Manuela Grimstein , Liuya Tang , Shyam Kalavar , Abdelrahmman Abukhdeir , Anand Pathak , Soma Ghosh , Ilynn Bulatao , Amy Tilley , William F Pierce , Bronwyn D Mixter , Shenghui Tang , Paul Kluetz , Laleh Amiri-Kordestani

FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.

The oncologist
Avec: Gautam U Mehta , Paz J Vellanki , Yi Ren , Anup K Amatya , Pallavi S Mishra-Kalyani , Lili Pan , Jeanne F Zirkelbach , Yuzhuo Pan , Jiang Liu , Stephanie L Aungst , Claudia P Miller , Mirat Shah , Nam Atiqur Rahman , Marc Theoret , Paul Kluetz , Julia A Beaver , Harpreet Singh

False-Positive Circulating Tumor DNA Results Do Not Explain Lack of Efficacy for PARP Inhibitors in Patients With Castration-Resistant Prostate Cancer Harboring

JCO precision oncology
Avec: Jaleh Fallah , Jianjin Xu , Hee-Koung Joeng , Chana Weinstock , Brian L Heiss , William F Maguire , Xin Gao , Joyce Cheng , Elaine Chang , Sundeep Agrawal , Mallorie H Fiero , Paul G Kluetz , Laleh Amiri-Kordestani , Daniel L Suzman

FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint inhibitors for the Treatment of Biliary Tract Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Sandra J Casak , Vaibhav Kumar , Chi Song , Mengdie Yuan , Anup K Amatya , Joyce Cheng , Pallavi S Mishra-Kalyani , Shenghui Tang , Steven J Lemery , Doris Auth , Gina Davis , Paul G Kluetz , Lola A Fashoyin-Aje

FDA Approval Summary: Belzutifan for Patients with Advanced Renal Cell Carcinoma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Jaleh Fallah , Brian L Heiss , Hee-Koung Joeng , Chana Weinstock , Xin Gao , William F Pierce , Benjamin Chukwurah , Vishal Bhatnagar , Mallorie H Fiero , Laleh Amiri-Kordestani , Paul G Kluetz , Daniel L Suzman

An FDA Review of Drug Development in Nonmetastatic Castration-resistant Prostate Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Michael Brave , Chana Weinstock , Jamie R Brewer , Dow-Chung Chi , Daniel L Suzman , Joyce Cheng , Lijun Zhang , Rajeshwari Sridhara , Amna Ibrahim , Paul G Kluetz , Julia A Beaver

Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs.

The oncologist
Avec: Janice Kim , Abhilasha Nair , Patricia Keegan , Julia A Beaver , Paul G Kluetz , Meredith Chuk , Gideon M Blumenthal

Eligibility and Radiologic Assessment for Adjuvant Clinical Trials in Kidney Cancer.

JAMA oncology
Avec: Sundeep Agrawal , Naomi B Haas , Mohammadhadi Bagheri , Brian R Lane , Jonathan Coleman , Hans Hammers , Gennady Bratslavsky , Cynthia Chauhan , Lauren Kim , Venkatesh P Krishnasamy , Jamie Marko , Virginia Ellen Maher , Amna Ibrahim , Frank Cross , Ke Liu , Julia A Beaver , Gideon M Blumenthal , Harpreet Singh , Elizabeth R Plimack , Toni K Choueiri , Robert Uzzo , Andrea B Apolo

A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials.

Annals of oncology : official journal of the European Society for Medical Oncology
Avec: L Amiri-Kordestani , D Xie , S M Tolaney , E Bloomquist , S Tang , A Ibrahim , K B Goldberg , M R Theoret , R Pazdur , R Sridhara , E P Winer , J A Beaver

FDA approval summary: Dalteparin for the treatment of symptomatic venous thromboembolism in pediatric patients.

Pediatric blood & cancer
Avec: Margret Merino , Nicholas Richardson , Gregory Reaman , Anusha Ande , Simbarashe Zvada , Chao Liu , Sudharshan Hariharan , R Angelo De Claro , Ann Farrell ,

FDA Approval Summary: Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

The oncologist
Avec: Donna Przepiorka , Lola Luo , Sriram Subramaniam , Junshan Qiu , Ramadevi Gudi , Lea C Cunningham , Lei Nie , Ruby Leong , Lian Ma , Christopher Sheth , Albert Deisseroth , Kirsten B Goldberg , Gideon M Blumenthal ,

FDA Approval Summary: Tagraxofusp-erzs For Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Emily Y Jen , Xin Gao , Liang Li , Luning Zhuang , Natalie E Simpson , Baikuntha Aryal , Rong Wang , Donna Przepiorka , Yuan Li Shen , Ruby Leong , Chao Liu , Christopher M Sheth , Steven Bowen , Kirsten B Goldberg , Ann T Farrell , Gideon M Blumenthal ,

Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Renal Cell Carcinoma.

Clinical pharmacology and therapeutics
Avec: G K Raju , Karthik Gurumurthi , Reuben Domike , Harpreet Singh , Chana Weinstock , Paul Kluetz , Janet Woodcock

U.S. Food and Drug Administration Benefit-Risk Assessment of Nilotinib Treatment Discontinuation in Patients with Chronic Phase Chronic Myeloid Leukemia in a Sustained Molecular Remission.

The oncologist
Avec: E Dianne Pulte , Tanya Wroblewski , Erik Bloomquist , Shenghui Tang , Ann Farrell , Albert Deisseroth , Amy E McKee ,

FDA Approval Summary: Brentuximab Vedotin in First-Line Treatment of Peripheral T-Cell Lymphoma.

The oncologist
Avec: Nicholas C Richardson , Yvette L Kasamon , Haiyan Chen , R Angelo de Claro , Jingjing Ye , Gideon M Blumenthal , Ann T Farrell ,

Eligibility and Radiologic Assessment in Adjuvant Clinical Trials in Bladder Cancer.

JAMA oncology
Avec: Andrea B Apolo , Matthew I Milowsky , Lauren Kim , Brant A Inman , Ashish M Kamat , Gary Steinberg , Mohammadhadi Bagheri , Venkatesh P Krishnasamy , Jamie Marko , Colin P Dinney , Rick Bangs , Randy F Sweis , Virginia Ellen Maher , Amna Ibrahim , Ke Liu , Ryan Werntz , Frank Cross , Julia A Beaver , Harpreet Singh , Gideon M Blumenthal , Seth P Lerner , Dean F Bajorin , Jonathan E Rosenberg , Sundeep Agrawal

FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Erica C Nakajima , Paz J Vellanki , Erin Larkins , Somak Chatterjee , Pallavi S Mishra-Kalyani , Youwei Bi , Hisham Qosa , Jiang Liu , Hong Zhao , Missiratch Biable , Lauren Tesh Hotaki , Yuan-Li Shen , Julia A Beaver , Harpreet Singh , Martha Donoghue

FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: E Dianne Pulte , Kelly J Norsworthy , Yaping Wang , Qing Xu , Hisham Qosa , Ramadevi Gudi , Donna Przepiorka , Wentao Fu , Olanrewaju O Okusanya , Kirsten B Goldberg , R Angelo De Claro , Ann T Farrell ,

Project 2025: Proposals for the Continued Success of Drug Development in Acute Myeloid Leukemia.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Daniel A Pollyea , John Barrett , Courtney D DiNardo , Laura C Michaelis , Gail J Roboz , Robert Q Le , Kelly J Norsworthy , R Angelo de Claro , Marc R Theoret ,

FDA Approval Summary: Selumetinib for Plexiform Neurofibroma.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Denise Casey , Suzanne Demko , Arup Sinha , Pallavi S Mishra-Kalyani , Yuan-Li Shen , Sachia Khasar , M Anwar Goheer , Whitney S Helms , Lili Pan , Yuan Xu , Jianghong Fan , Ruby Leong , Jiang Liu , Yuching Yang , Katherine Windsor , Mei Ou , Olen Stephens , Byeongtaek Oh , Gregory H Reaman , Abhilasha Nair , Stacy S Shord , Vishal Bhatnagar , Selena R Daniels , Sharon Sickafuse , Kirsten B Goldberg , Marc R Theoret , Harpreet Singh

FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Preeti Narayan , Christy L Osgood , Harpreet Singh , Haw-Jyh Chiu , Tiffany K Ricks , Edwin Chiu Yuen Chow , Junshan Qiu , Pengfei Song , Jingyu Yu , Frances Namuswe , Maria Guiterrez-Lugo , Sherry Hou , William F Pierce , Kirsten B Goldberg , Shenghui Tang , Laleh Amiri-Kordestani , Marc R Theoret , Julia A Beaver

FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Sakar Wahby , Lola Fashoyin-Aje , Christy L Osgood , Joyce Cheng , Mallorie H Fiero , Lijun Zhang , Shenghui Tang , Salaheldin S Hamed , Pengfei Song , Rosane Charlab , Sarah E Dorff , Tiffany K Ricks , Kimberly Barnett-Ringgold , Jeannette Dinin , Kirsten B Goldberg , Marc R Theoret , Laleh Amiri-Kordestani , Julia A Beaver

FDA Approval Summary: Entrectinib for the Treatment of

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Leigh Marcus , Martha Donoghue , Stephanie Aungst , Claire E Myers , Whitney S Helms , Guoxiang Shen , Hong Zhao , Olen Stephens , Patricia Keegan ,

FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Avec: Melanie Royce , Christy Osgood , Flora Mulkey , Erik Bloomquist , William F Pierce , Arpita Roy , Shyam Kalavar , Soma Ghosh , Reena Philip , Fatima Rizvi , Bronwyn D Mixter , Shenghui Tang , Julia A Beaver , Laleh Amiri-Kordestani

US Food and Drug Administration regulatory updates in neuro-oncology.

Journal of neuro-oncology
Avec: Gautam U Mehta , Amy K Barone , Diana Bradford , Erin Larkins , Janice Kim , Lee Pai-Scherf , Adnan Jaigirdar , Mirat Shah , Suparna Wedam , Laleh Amiri-Kordestani , Marc R Theoret , Julia A Beaver , Harpreet Singh

FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Sandra J Casak , Shan Pradhan , Lola A Fashoyin-Aje , Yi Ren , Yuan-Li Shen , Yuan Xu , Edwin Chiu Yuen Chow , Ye Xiong , Jeanne Fourie Zirklelbach , Jiang Liu , Rosane Charlab , William F Pierce , Nataliya Fesenko , Julia A Beaver , Paul G Kluetz , Steven J Lemery

FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease-Associated Tumors.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Jaleh Fallah , Michael H Brave , Chana Weinstock , Gautam U Mehta , Diana Bradford , Haley Gittleman , Erik W Bloomquist , Rosane Charlab , Salaheldin S Hamed , Claudia P Miller , Sarah E Dorff , Wiley A Chambers , Bronwyn D Mixter , Jeannette Dinin , William F Pierce , Tiffany K Ricks , Shenghui Tang , Martha Donoghue , Laleh Amiri-Kordestani , Amna Ibrahim , Julia A Beaver

Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Avec: Jeanne Fourie Zirkelbach , Mirat Shah , Jonathon Vallejo , Joyce Cheng , Amal Ayyoub , Jiang Liu , Rachel Hudson , Rajeshwari Sridhara , Gwynn Ison , Laleh Amiri-Kordestani , Shenghui Tang , Thomas Gwise , Atiqur Rahman , Marc R Theoret

FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Shruti U Gandhy , Sandra J Casak , Sirisha L Mushti , Joyce Cheng , Sriram Subramaniam , Hong Zhao , Miao Zhao , Youwei Bi , Guansheng Liu , Jianghong Fan , Oluseyi Adeniyi , Rosane Charlab , Dubravka Kufrin , Matthew D Thompson , Kristin Jarrell , Doris Auth , Steven J Lemery , Paul G Kluetz , Lola A Fashoyin-Aje

FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Sandra J Casak , M Naomi Horiba , Mengdie Yuan , Joyce Cheng , Steven J Lemery , Yuan Li Shen , Wentao Fu , Jason N Moore , Yangbing Li , Youwei Bi , Doris Auth , Nataliya Fesenko , Paul G Kluetz , Lola A Fashoyin-Aje

Trends in the approval of cancer therapies by the FDA in the twenty-first century.

Nature reviews. Drug discovery
Avec: Emma C Scott , Andrea C Baines , Yutao Gong , Rodney Moore , Gulsum E Pamuk , Haleh Saber , Ashim Subedee , Matthew D Thompson , Wenming Xiao , V Ashutosh Rao , Julie Schneider , Julia A Beaver

Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development.

Cancer discovery
Avec: Joshua M Donaldson , Marjilla Seddiq , Michael J Fusco , Shyamli Singla , Gulsum E Pamuk , Rosa J Lee-Alonso , Bronwyn D Mixter , Kirsten B Goldberg , Laleh Amiri-Kordestani , R Angelo de Claro , Nicole Drezner , Nicole J Gormley , Bindu Kanapuru , Steven J Lemery , Lola A Fashoyin-Aje , Nicholas C Richardson , Harpreet Singh , Daniel L Suzman , Marc R Theoret , Paul G Kluetz ,

FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Ashley Woods , Kelly J Norsworthy , Xin Wang , Jonathon Vallejo , Edwin C Y Chow , Ruo-Jing Li , Jielin Sun , Rosane Charlab , Xiling Jiang , Marc R Theoret , R Angelo de Claro

Review of Racial and Ethnic Representation of Participants Enrolled in Pediatric Clinical Trials of Oncology Drugs Conducted Through FDA Written Requests.

JAMA oncology
Avec: Lola A Fashoyin-Aje , Alemayehu Y Akalu , Jessica Boehmer , Martha Donoghue , Gregory H Reaman

FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Jaleh Fallah , Sundeep Agrawal , Haley Gittleman , Mallorie H Fiero , Sriram Subramaniam , Christy John , Wei Chen , Tiffany K Ricks , Gang Niu , Anthony Fotenos , Min Wang , Kelly Chiang , William F Pierce , Daniel L Suzman , Shenghui Tang , Laleh Amiri-Kordestani , Amna Ibrahim , Paul G Kluetz

FDA Oncology Center of Excellence Crowdsourcing Initiative: Outreach to the Scientific Community to Identify Research Questions for Pooled Analyses of Oncology Clinical Trial Data.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Julie A Schneider , Julia Eckstein , Kirsten B Goldberg , Mark C Ascione , Thamar Bailey , Kimberly Taylor , Aisha M Coffey , Darshini Satchi , Howard Philips , Rajeshwari Sridhara , Abhilasha Nair , Marc R Theoret

Reflections and Roadmaps: Career Development Beyond the FDA-AACR Oncology Educational Fellowship.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Timil Patel , Chris Chen , Samer Al Hadidi , Yasmin Kadry , Rajeshwari Sridhara , Erin Purcell , Laura Wisch , Jon Retzlaff , Margaret Foti , Paul Kluetz , Jennifer Gao

US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer With

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Avec: Asma Dilawari , James Buturla , Christy Osgood , Xin Gao , Wei Chen , Tiffany K Ricks , Timothy Schaefer , Sreedevi Avasarala , Francisca Reyes Turcu , Anand Pathak , Shyam Kalavar , Vishal Bhatnagar , Justin Collazo , Nam Atiqur Rahman , Bronwyn Mixter , Shenghui Tang , Paul Kluetz , Laleh Amiri-Kordestani

Equipoise Lost? Trial Conduct Challenges in an Era of Breakthrough Therapies.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Avec: Jaleh Fallah , Flora Mulkey , Mallorie H Fiero , Haley Gittleman , Chi Song , Jeevan Puthiamadathil , Anup Amatya , Sundeep Agrawal , Paz Vellanki , Daniel L Suzman , Harpreet Singh , Laleh Amiri-Kordestani , Pallavi Mishra-Kalyani , Paul G Kluetz

FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Ashley C Woods , Kelly J Norsworthy , Moran Choe , Brenda J Gehrke , Haiyan Chen , Jonathon Vallejo , Lili Pan , Xiling Jiang , Hongshan Li , Jeffrey Kraft , Jiang Liu , Rosane Charlab , Olanrewaju O Okusanya , Brian Booth , Marc R Theoret , R Angelo de Claro

FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Shaily Arora , Sanjeeve Balasubramaniam , Wei Zhang , Lijun Zhang , Rajeshwari Sridhara , Dianne Spillman , Jaigi P Mathai , Bradley Scott , Sarah J Golding , Michael Coory , Julia A Beaver

Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Jamie R Brewer , Elaine Chang , Sundeep Agrawal , Harpreet Singh , Daniel L Suzman , James Xu , Chana Weinstock , Laura L Fernandes , Joyce Cheng , Lijun Zhang , Diqiong Xie , Kirsten B Goldberg , Erik W Bloomquist , Shenghui Tang , Rajeshwari Sridhara , Marc R Theoret , Amna Ibrahim , Julia A Beaver

Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy.

Current oncology reports
Avec: Sirisha L Mushti , Flora Mulkey , Shenghui Tang , Harpreet Singh , Steven J Lemery , Kirsten B Goldberg , Rajeshwari Sridhara , Patricia Keegan , Paul G Kluetz , Marc R Theoret , Julia A Beaver

Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Avec: Lynn J Howie , Harpreet Singh , Erik Bloomquist , Suparna Wedam , Laleh Amiri-Kordestani , Shenghui Tang , Rajeshwari Sridhara , Jacqueline Sanchez , Tatiana M Prowell , Paul G Kluetz , Belinda L King-Kallimanis , Jennifer J Gao , Amna Ibrahim , Kirsten B Goldberg , Marc Theoret , Julia A Beaver

Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop.

The Journal of urology
Avec: Chana Weinstock , Daniel Suzman , Paul Kluetz , John Baxley , Charles Viviano , Amna Ibrahim , Jonathan Jarow , Raejshwari Sridhara , Ke Liu , Peter Carroll , Scott Eggener , Jim C Hu , Maha Hussain , Martin King , Eric Klein , Terry Kungel , Danil Makarov , Peter A Pinto , Brian Rini , Mack Roach , Howard Sandler , Peter N Schlegel , Daniel Song , Kirsten Goldberg , Julia A Beaver

Prognostic Value of the Lung Immune Prognostic Index for Patients Treated for Metastatic Non-Small Cell Lung Cancer.

JAMA oncology
Avec: Dickran Kazandjian , Yutao Gong , Patricia Keegan , Gideon M Blumenthal

FDA Approval Summary: Tisagenlecleucel for Treatment of Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Maura C O'Leary , Xiaobin Lu , Ying Huang , Xue Lin , Iftekhar Mahmood , Donna Przepiorka , Denise Gavin , Shiowjen Lee , Ke Liu , Bindu George , Wilson Bryan , Marc R Theoret ,

Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Avec: V Ellen Maher , Laura L Fernandes , Chana Weinstock , Shenghui Tang , Sundeep Agarwal , Michael Brave , Yang-Min Ning , Harpreet Singh , Daniel Suzman , James Xu , Kirsten B Goldberg , Rajeshwari Sridhara , Amna Ibrahim , Marc Theoret , Julia A Beaver ,

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Melanie Royce , Christy L Osgood , Anup K Amatya , Mallorie H Fiero , C J George Chang , Tiffany K Ricks , Krithika A Shetty , Jeffrey Kraft , Junshan Qiu , Pengfei Song , Rosane Charlab , Jingyu Yu , Kathryn E King , Anshu Rastogi , Brian Janelsins , Wendy C Weinberg , Kathleen Clouse , Vicky Borders-Hemphill , Lindsey Brown , Candace Gomez-Broughton , Zhong Li , Thuy Thanh Nguyen , Zhihao Qiu , Anh-Thy Ly , Suyoung Chang , Tingting Gao , Chi-Ming Tu , Bellinda King-Kallimanis , William F Pierce , Kelly Chiang , Clara Lee , Kirsten B Goldberg , John K Leighton , Shenghui Tang , Julia A Beaver , Laleh Amiri-Kordestani

FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC.

Clinical cancer research : an official journal of the American Association for Cancer Research
Avec: Erica C Nakajima , Nicole Drezner , Xiaoxue Li , Pallavi S Mishra-Kalyani , Yajun Liu , Hong Zhao , Youwei Bi , Jiang Liu , Atiqur Rahman , Emily Wearne , Idara Ojofeitimi , Lauren Tesh Hotaki , Dianne Spillman , Julia A Beaver , Harpreet Singh

Réseau de co-auteurs

Julia A Beaver 38 collaborations
Kirsten B Goldberg 29 collaborations
Marc R Theoret 28 collaborations
Shenghui Tang 28 collaborations
Laleh Amiri-Kordestani 28 collaborations
Paul G Kluetz 26 collaborations
Harpreet Singh 22 collaborations
Rajeshwari Sridhara 17 collaborations
William F Pierce 15 collaborations
Amna Ibrahim 14 collaborations
Joyce Cheng 14 collaborations
Daniel L Suzman 13 collaborations
Chana Weinstock 12 collaborations
Jiang Liu 12 collaborations
Tiffany K Ricks 12 collaborations
Gideon M Blumenthal 12 collaborations
Mallorie H Fiero 12 collaborations
Hong Zhao 10 collaborations
R Angelo de Claro 10 collaborations
Pallavi S Mishra-Kalyani 10 collaborations
Lola A Fashoyin-Aje 10 collaborations
Steven J Lemery 10 collaborations
Martha Donoghue 9 collaborations
Xin Gao 9 collaborations
Rosane Charlab 9 collaborations
Soma Ghosh 8 collaborations
Patricia Keegan 8 collaborations
Mirat Shah 8 collaborations
Paul Kluetz 8 collaborations
Donna Przepiorka 8 collaborations
Jonathon Vallejo 8 collaborations
Sundeep Agrawal 8 collaborations
Lola Fashoyin-Aje 7 collaborations
Elaine Chang 7 collaborations
Erik Bloomquist 7 collaborations
Reena Philip 7 collaborations
Christy L Osgood 7 collaborations
Vishal Bhatnagar 7 collaborations
Bindu Kanapuru 7 collaborations
Flora Mulkey 6 collaborations
Jennifer J Gao 6 collaborations
Erik W Bloomquist 6 collaborations
Jingyu Yu 6 collaborations
Suparna Wedam 6 collaborations
Shyam Kalavar 6 collaborations
Jaleh Fallah 6 collaborations
Yutao Gong 5 collaborations
Dianne Spillman 5 collaborations
Junshan Qiu 5 collaborations
Pengfei Song 5 collaborations
Nam Atiqur Rahman 5 collaborations
Lijun Zhang 5 collaborations
Yuan Li Shen 5 collaborations
Yangbing Li 5 collaborations
Gwynn Ison 5 collaborations
Melanie Royce 5 collaborations
Laura L Fernandes 5 collaborations
Andrea C Baines 5 collaborations
Rachel Ershler 5 collaborations
Yuan-Li Shen 5 collaborations
Olanrewaju O Okusanya 5 collaborations
Kelly J Norsworthy 5 collaborations
Youwei Bi 5 collaborations
Ann T Farrell 5 collaborations
Sandra J Casak 5 collaborations
Haley Gittleman 5 collaborations
Bronwyn D Mixter 5 collaborations
Shaily Arora 4 collaborations
Paz J Vellanki 4 collaborations
Xiling Jiang 4 collaborations
Marc Theoret 4 collaborations
Nicole Drezner 4 collaborations
Tatiana M Prowell 4 collaborations
Danielle Krol 4 collaborations
Ruby Leong 4 collaborations
Lian Ma 4 collaborations
Nicole J Gormley 4 collaborations
Sriram Subramaniam 4 collaborations
Haiyan Chen 4 collaborations
Brian L Heiss 4 collaborations
Wentao Fu 4 collaborations
Erin Larkins 4 collaborations
Anup K Amatya 4 collaborations
Yvette L Kasamon 4 collaborations
Leigh Marcus 4 collaborations
Albert Deisseroth 4 collaborations
Amy E McKee 4 collaborations
Salaheldin S Hamed 4 collaborations
Jianghong Fan 4 collaborations
Ke Liu 4 collaborations
Mengdie Yuan 3 collaborations
Lisa Rodriguez 3 collaborations
Yuan Xu 3 collaborations
Hui Zhang 3 collaborations
Haw-Jyh Chiu 3 collaborations
Andrea B Apolo 3 collaborations
Daniel Suzman 3 collaborations
Xiaoxue Li 3 collaborations
Jeanne Fourie Zirkelbach 3 collaborations
Nataliya Fesenko 3 collaborations
R Pazdur 3 collaborations
Preeti Narayan 3 collaborations
Sakar Wahby 3 collaborations
Thomas Gwise 3 collaborations
Robert Q Le 3 collaborations
Qing Xu 3 collaborations
Michael H Brave 3 collaborations
Jeffrey Kraft 3 collaborations
Ruo-Jing Li 3 collaborations
Ramadevi Gudi 3 collaborations
Yuching Yang 3 collaborations
R Angelo De Claro 3 collaborations
William F Maguire 3 collaborations
Fang Li 3 collaborations
Jeannette Dinin 3 collaborations
Diana Bradford 3 collaborations
Yi Ren 3 collaborations
Claudia P Miller 3 collaborations
Chao Liu 3 collaborations
Bindu George 3 collaborations
Xue Lin 3 collaborations
Emily Y Jen 3 collaborations
Ann Farrell 3 collaborations
Whitney S Helms 3 collaborations
Atiqur Rahman 3 collaborations
Lauren Tesh Hotaki 3 collaborations
Wei Chen 3 collaborations
Sirisha L Mushti 3 collaborations
Christy Osgood 3 collaborations
Nicholas C Richardson 3 collaborations
Jamie R Brewer 3 collaborations
Gautam U Mehta 3 collaborations
Lili Pan 3 collaborations
Doris Auth 3 collaborations
Abhilasha Nair 3 collaborations
May Tun Saung 2 collaborations
Lorraine Pelosof 2 collaborations
Sandra Casak 2 collaborations
Steven Lemery 2 collaborations
Meredith Chuk 2 collaborations
Gina Davis 2 collaborations
Oluseyi Adeniyi 2 collaborations
Adnan A Jaigirdar 2 collaborations
Qiuyi Choo 2 collaborations
Sarah J Golding 2 collaborations
Kwadwo Korsah 2 collaborations
Fatima Rizvi 2 collaborations
Sherry Hou 2 collaborations
Lynn J Howie 2 collaborations
Jason Schroeder 2 collaborations
Barbara Scepura 2 collaborations
Tamy Kim 2 collaborations
Jessica Boehmer 2 collaborations
Rick Bangs 2 collaborations
Ashish M Kamat 2 collaborations
Seth P Lerner 2 collaborations
Huiming Xia 2 collaborations
Ulrich-Peter Rohr 2 collaborations
A Ibrahim 2 collaborations
S Tang 2 collaborations
R Sridhara 2 collaborations
P G Kluetz 2 collaborations
J A Beaver 2 collaborations
Tara Berman 2 collaborations
Christina Brus 2 collaborations
Elizabeth Pulte 2 collaborations
Nicole Gormley 2 collaborations
Xin Wang 2 collaborations
Hongshan Li 2 collaborations
Guoxiang Shen 2 collaborations
Liang Li 2 collaborations
Natalie E Simpson 2 collaborations
Michael L Manning 2 collaborations
Brenda J Gehrke 2 collaborations
Ankit Shah 2 collaborations
Salaheldin Hamed 2 collaborations
Amy Tilley 2 collaborations
Liuya Tang 2 collaborations
Abdelrahmman Abukhdeir 2 collaborations
Paresma Patel 2 collaborations
Jon Retzlaff 2 collaborations
Margaret Foti 2 collaborations
Sachia Khasar 2 collaborations
Stacy S Shord 2 collaborations
Lei Nie 2 collaborations
Jingjing Ye 2 collaborations
K B Goldberg 2 collaborations
Frances Namuswe 2 collaborations
Shiowjen Lee 2 collaborations
Wilson Bryan 2 collaborations
Yang-Min Ning 2 collaborations
V Ellen Maher 2 collaborations
Lee Pai-Scherf 2 collaborations
Pallavi Mishra-Kalyani 2 collaborations
Rajan Pragani 2 collaborations
Xinyuan Zhang 2 collaborations
Timil H Patel 2 collaborations
M Naomi Horiba 2 collaborations
Somak Chatterjee 2 collaborations
Asma Dilawari 2 collaborations
Arpita Roy 2 collaborations
C J George Chang 2 collaborations
Jianjin Xu 2 collaborations
Anand Pathak 2 collaborations
Hee-Koung Joeng 2 collaborations
Chi Song 2 collaborations
Michael Brave 2 collaborations
Janice Kim 2 collaborations
Mohammadhadi Bagheri 2 collaborations
Lauren Kim 2 collaborations
Venkatesh P Krishnasamy 2 collaborations
Jamie Marko 2 collaborations
Virginia Ellen Maher 2 collaborations
Frank Cross 2 collaborations
E Dianne Pulte 2 collaborations
Erica C Nakajima 2 collaborations
Hisham Qosa 2 collaborations
Olen Stephens 2 collaborations
Gregory H Reaman 2 collaborations
Edwin Chiu Yuen Chow 2 collaborations
Sarah E Dorff 2 collaborations
Matthew D Thompson 2 collaborations
Gulsum E Pamuk 2 collaborations
Kelly Chiang 2 collaborations
James Xu 2 collaborations
Peter Schotland 1 collaboration
Mitchell S Anscher 1 collaboration
Sarah Zimmerman 1 collaboration
Maritsa Serlemitsos-Day 1 collaboration
Yang Min Ning 1 collaboration
Ruth Mayrosh 1 collaboration
Barbara Fuller 1 collaboration
Ann Marie Trentacosti 1 collaboration
Pamela Gallagher 1 collaboration
Karen Bijwaard 1 collaboration
Frances Fahnbulleh 1 collaboration
Felicia Diggs 1 collaboration
Yibo Wang 1 collaboration
Grant Howe 1 collaboration
Jian Wang 1 collaboration
Victoria Mansell 1 collaboration
Willie Wilson 1 collaboration
Abde M Abukhdeir 1 collaboration
Jeffrey Seidman 1 collaboration
Sirisha Mushti 1 collaboration
Maryam Khazraee 1 collaboration
Jessica K Roydhouse 1 collaboration
Laurel A Menapace 1 collaboration
Nancy S Scher 1 collaboration
Bellinda L King-Kallimanis 1 collaboration
Yasmin Choudhry 1 collaboration
Mitchell Chan 1 collaboration
Stephanie Chisolm 1 collaboration
Vinay Duddalwar 1 collaboration
Jason A Efstathiou 1 collaboration
Donna E Hansel 1 collaboration
Elizabeth Plimack 1 collaboration
Tatiana Prowell 1 collaboration
Evan Y Yu 1 collaboration
Matthew D Galsky 1 collaboration
Abigail L Koch 1 collaboration
Elitza Palazov 1 collaboration
Aleksandr Gamarian 1 collaboration
Arūnas Girčys 1 collaboration
P S Mishra-Kalyani 1 collaboration
L Amiri Kordestani 1 collaboration
D R Rivera 1 collaboration
H Singh 1 collaboration
R A DeClaro 1 collaboration
Y Shen 1 collaboration
J Concato 1 collaboration
Hongfei Zhang 1 collaboration
Angelo De Claro 1 collaboration
Wanda Nguyen 1 collaboration
Nina Kim 1 collaboration
Eliford Kitabi 1 collaboration
Justin Earp 1 collaboration
Lori A Ehrlich 1 collaboration
Tien Truong 1 collaboration
Alexei Ionan 1 collaboration
Ying-Hong Wang 1 collaboration
Soumya Mitra 1 collaboration
Djelila Mezaache 1 collaboration
Rakhi Shah 1 collaboration
Anamitro Banerjee 1 collaboration
Sherita McLamore 1 collaboration
Adam N Maung 1 collaboration
Luckson N Mathieu 1 collaboration
Arup K Sinha 1 collaboration
Samina Jafri 1 collaboration
Craig Tendler 1 collaboration
Bea Lavery 1 collaboration
Serban Ghiorghiu 1 collaboration
Brittany Gerald 1 collaboration
Chitkala Kalidas 1 collaboration
Nicole Richie 1 collaboration
Kathleen Winson 1 collaboration
Nicholas J H Warren 1 collaboration
Tristen V Tellman 1 collaboration
Michael I Barbato 1 collaboration
Jeannette Nashed 1 collaboration
Banu S Zolnik 1 collaboration
Raniya A Al-Matari 1 collaboration
G M Blumenthal 1 collaboration
Y Gong 1 collaboration
K Kehl 1 collaboration
P Mishra-Kalyani 1 collaboration
S Khozin 1 collaboration
G R Oxnard 1 collaboration
Runyan Jin 1 collaboration
Xianhua Cao 1 collaboration
Xu Michael Di 1 collaboration
Najat Bouchkouj 1 collaboration
Aaron Schetter 1 collaboration
Donna Roscoe 1 collaboration
Stella Karuri 1 collaboration
Huanyu Chen 1 collaboration
Kun He 1 collaboration
Janaki Veeraraghavan 1 collaboration
Jiaxi Zhou 1 collaboration
Luckson Mathieu 1 collaboration
Sujay Shah 1 collaboration
Sonia Singh 1 collaboration
Anwar Goheer 1 collaboration
Xing Wang 1 collaboration
Rajiv Agarwal 1 collaboration
John Leighton 1 collaboration
Michael Shum 1 collaboration
Laila Sofia Mouawad 1 collaboration
Gustavo Mendes Lima Santos 1 collaboration
Kelly Robinson 1 collaboration
Melissa Hunt 1 collaboration
Caroline Healy 1 collaboration
Agnes Chan 1 collaboration
Yee Hoo Looi 1 collaboration
Clare Rodrigues 1 collaboration
Chantal Walther 1 collaboration
Xiao Hong Chen 1 collaboration
Leah Her 1 collaboration
Suparna B Wedam 1 collaboration
Peter M Voorhees 1 collaboration
Andrzej J Jakubowiak 1 collaboration
Shaji K Kumar 1 collaboration
Poornima Sharma 1 collaboration
Zhenzhen Xu 1 collaboration
Wilson W Bryan 1 collaboration
Robert N Schuck 1 collaboration
Wimolnut Manheng 1 collaboration
Arulvathani Arudchandran 1 collaboration
Shadia Zaman 1 collaboration
Andrea Baines 1 collaboration
Maryam Sarraf Yazdy 1 collaboration
Ashley Lane 1 collaboration
Theresa Carioti 1 collaboration
Zhou Feng 1 collaboration
Sherry C Hou 1 collaboration
Donna R Rivera 1 collaboration
Jiaxin Fan 1 collaboration
Yue Xiang 1 collaboration
Hima Lingam 1 collaboration
Nikolett Biel 1 collaboration
Jillian Jielin Sun 1 collaboration
Robert Schuck 1 collaboration
Manuela Grimstein 1 collaboration
Ilynn Bulatao 1 collaboration
Jeanne F Zirkelbach 1 collaboration
Yuzhuo Pan 1 collaboration
Stephanie L Aungst 1 collaboration
Vaibhav Kumar 1 collaboration
Benjamin Chukwurah 1 collaboration
Dow-Chung Chi 1 collaboration
Naomi B Haas 1 collaboration
Brian R Lane 1 collaboration
Jonathan Coleman 1 collaboration
Hans Hammers 1 collaboration
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