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

Antineoplastic Agents Asparaginase Child Disease-Free Survival Humans Polyethylene Glycols Precursor Cell Lymphoblastic Leukemia-Lymphoma Young Adult

Journal

Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500

Informations de publication

Date de publication:
15 01 2020
Historique:
received: 19 04 2019
revised: 06 06 2019
accepted: 21 08 2019
pubmed: 25 8 2019
medline: 4 8 2020
entrez: 25 8 2019
Statut: ppublish

Résumé

On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (CALASP), an asparagine-specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years. Efficacy was determined on the basis of achievement and maintenance of steady-state nadir serum asparaginase activity (NSAA) above 0.1 U/mL when using CALASP, 2,500 U/m

Identifiants

DOI: 10.1158/1078-0432.CCR-19-1255 PMID: 31444252
pubmed: 31444252
pii: 1078-0432.CCR-19-1255
doi: 10.1158/1078-0432.CCR-19-1255
doi:

Substances chimiques

Antineoplastic Agents 0
Polyethylene Glycols 3WJQ0SDW1A
Asparaginase EC 3.5.1.1
calaspargase pegol EC 3.5.1.1

Types de publication

Journal Article Comment

Langues

eng

Sous-ensembles de citation

IM

Pagination

328-331

Commentaires et corrections

Type : CommentIn
Type : CommentOn

Informations de copyright

©2019 American Association for Cancer Research.

Auteurs

Ruo-Jing Li (RJ)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. ruojing.li@fda.hhs.gov.
ORCID: 0000-0001-7559-3929

Runyan Jin (R)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Chao Liu (C)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Xianhua Cao (X)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Michael L Manning (ML)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Xu Michael Di (XM)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Donna Przepiorka (D)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Frances Namuswe (F)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Albert Deisseroth (A)

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

Kirsten B Goldberg (KB)

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

Gideon M Blumenthal (GM)

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

Richard Pazdur (R)

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Antinéoplasiques › FDA Approval Summary: Calaspargase Pegol-mknl...
questionsmedicales.fr › Enzymes et coenzymes › Enzymes › Hydrolases › Amidohydrolases › Asparaginase › FDA Approval Summary: Calaspargase Pegol-mknl...
questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › FDA Approval Summary: Calaspargase Pegol-mknl...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Analyse de survie › Survie sans rechute › FDA Approval Summary: Calaspargase Pegol-mknl...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › FDA Approval Summary: Calaspargase Pegol-mknl...
questionsmedicales.fr › Technologie, industrie et agriculture › Produits manufacturés › Matériaux biomédicaux et dentaires › Polymères › Polyéthylène glycols › FDA Approval Summary: Calaspargase Pegol-mknl...
questionsmedicales.fr › Maladies du système immunitaire › Syndromes immunoprolifératifs › Syndromes lymphoprolifératifs › Leucémie lymphoïde › Leucémie-lymphome lymphoblastique à précurseurs B et T › FDA Approval Summary: Calaspargase Pegol-mknl...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Jeune adulte › FDA Approval Summary: Calaspargase Pegol-mknl...