FDA Approval Summary: Capecitabine Labeling Update under Project Renewal.

Autor: Agrawal S; United States Food and Drug Administration, Silver Spring, MD, United States., Lee C; United States Food and Drug Administration, Silver Spring, Maryland, United States., Pierce WF; Food and Drug Administration, Silver Spring, Maryland, United States., Everhart E; United States Food and Drug Administration, Silver Spring, MD, United States., King-Ducre A; Food and Drug Administration, Silver Spring, Maryland, United States., Royce M; United States Food and Drug Administration, Silver Spring, Maryland, United States., Osgood CL; United States Food and Drug Administration, Silver Spring, MD, United States., Amiri-Kordestani L; Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, United States., Chiu HJ; Food and Drug Administration, Silver Spring, Maryland, United States., Ricks TK; United States Food and Drug Administration, Silver Spring, MD, United States., Pan L; United States Food and Drug Administration, Silver Spring, Maryland, United States., Fourie Zirkelbach J; United States Food and Drug Administration, Silver Spring, Maryland, United States., Charlab R; United States Food and Drug Administration, Silver Spring, MD, United States., Pacanowski M; United States Food and Drug Administration, Silver Spring, MD, United States., Kim T; United States Food and Drug Administration, Silver Spring, MD, United States., Pazdur R; United States Food and Drug Administration, Silver Spring, MD, United States., Kluetz PG; Food and Drug Administration, Silver Spring, MD, United States., Gao JJ; United States Food and Drug Administration, Silver Spring, MD, United States.
Jazyk: angličtina
Zdroj: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2024 Oct 08. Date of Electronic Publication: 2024 Oct 08.
DOI: 10.1158/1078-0432.CCR-24-1708
Abstrakt: On December 14, 2022, the U.S. Food and Drug Administration (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 (DPD) 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.
Databáze: MEDLINE