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

Journal

Cancer discovery
ISSN: 2159-8290
Titre abrégé: Cancer Discov
Pays: United States
ID NLM: 101561693

Informations de publication

Date de publication:
12 Dec 2023
Historique:
medline: 12 12 2023
pubmed: 12 12 2023
entrez: 12 12 2023
Statut: ppublish

Résumé

Cancer drug development remained robust in 2023. Highlights of U.S. drug approvals this year include new immunotherapies and targeted drug development in adult and pediatric patients as well as patients with rare diseases.

Identifiants

DOI: 10.1158/2159-8290.CD-23-1226 PMID: 38084090
pubmed: 38084090
pii: 731610
doi: 10.1158/2159-8290.CD-23-1226
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2515-2524

Informations de copyright

©2023 American Association for Cancer Research.

Auteurs

Joshua M Donaldson (JM)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0003-3879-833X

Marjilla Seddiq (M)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0003-1436-2136

Michael J Fusco (MJ)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-5883-7466

Shyamli Singla (S)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0009-0001-2828-2412

Gulsum E Pamuk (GE)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-2299-3758

Rosa J Lee-Alonso (RJ)

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0009-0007-9823-599X

Bronwyn D Mixter (BD)

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-5277-4399

Kirsten B Goldberg (KB)

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-8659-1240

Laleh Amiri-Kordestani (L)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-0056-5437

R Angelo de Claro (RA)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-8362-1977

Nicole Drezner (N)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-6299-9823

Nicole J Gormley (NJ)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-6379-5101

Bindu Kanapuru (B)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0003-1341-4686

Steven J Lemery (SJ)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-7415-1870

Lola A Fashoyin-Aje (LA)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-7328-7813

Nicholas C Richardson (NC)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0001-9378-9909

Harpreet Singh (H)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0003-1526-0916

Daniel L Suzman (DL)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-1702-6114

Marc R Theoret (MR)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0003-4973-5297

Paul G Kluetz (PG)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-9796-4791

Richard Pazdur (R)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
ORCID: 0000-0002-4771-9923

Classifications MeSH