FDA approval summary: Crizotinib for pediatric and young adult patients with relapsed or refractory systemic anaplastic large cell lymphoma.
anaplastic large cell lymphoma
crizotinib
pediatric lymphoma
Journal
Pediatric blood & cancer
ISSN: 1545-5017
Titre abrégé: Pediatr Blood Cancer
Pays: United States
ID NLM: 101186624
Informations de publication
Date de publication:
08 2022
08 2022
Historique:
revised:
07
01
2022
received:
27
10
2021
accepted:
27
01
2022
pubmed:
14
5
2022
medline:
28
6
2022
entrez:
13
5
2022
Statut:
ppublish
Résumé
In January 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). This is the first approval for pediatric sALCL. Approval was based on a single-arm trial of crizotinib monotherapy that included 26 patients, aged 1-20 years, with previously treated sALCL. Efficacy was based on centrally assessed objective response rate (88%) and duration of response. Herein, we highlight unique aspects of the regulatory review, including extension of the indication to young adults, postmarketing safety, and dose optimization strategies.
Substances chimiques
Immunoconjugates
0
Protein Kinase Inhibitors
0
Crizotinib
53AH36668S
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e29602Informations de copyright
Published 2022. This article is a U.S. Government work and is in the public domain in the USA.
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