FDA Approval Summary: Capecitabine Labeling Update under Project Renewal.

Autor:	Agrawal S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, Maryland., Lee C; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce WF; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, Maryland., Everhart E; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., King-Ducre A; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, Maryland., Royce M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Osgood CL; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Chiu HJ; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Pan L; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Fourie Zirkelbach J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Charlab R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Pacanowski M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland., Kim T; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, Maryland., Gao JJ; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence (OCE), U.S. Food and Drug Administration, Silver Spring, Maryland.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2024 Dec 16; Vol. 30 (24), pp. 5508-5514.
DOI:	10.1158/1078-0432.CCR-24-1708
Abstrakt:	On December 14, 2022, the FDA approved revisions to the United States Prescribing Information (USPI) for capecitabine that revised existing indications and dosage regimens, added new indications and their recommended dosage regimens, revised safety information, updated the description of the risk of capecitabine in patients with dihydropyrimidine dehydrogenase deficiency, and edited other sections of the USPI to conform with FDA's current labeling guidance. These supplements were reviewed and approved under Project Renewal, a public health initiative established by the FDA's Oncology Center of Excellence that aims to update the prescribing information of certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This article summarizes the FDA approach that supported revisions to the capecitabine USPI within the context of Project Renewal. (©2024 American Association for Cancer Research.)
Databáze:	MEDLINE
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