FDA Approval Summary: Capecitabine Labeling Update under Project Renewal

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.

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Publication Details

Journal
Clinical Cancer Research
Published
2024-10-08
DOI
https://doi.org/10.1158/1078-0432.ccr-24-1708
Citations
3
Primary Topic
Colorectal Cancer Treatments and Studies
Type
article
Field-Weighted Citation Impact
0.85

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article

FDA Approval Summary: Capecitabine Labeling Update under Project Renewal

Rosane Charlab, Melanie Royce, Jeanne Fourie Zirkelbach, Lili Pan et al.
3 citations
Clinical Cancer Research
Colorectal Cancer Treatments and Studies
0.85
article

FDA Approval Summary: Capecitabine Labeling Update under Project Renewal

Rosane Charlab, Melanie Royce, Jeanne Fourie Zirkelbach, Lili Pan, Tamy Kim, Haw-Jyh Chiu, Christy Osgood, Jennifer Gao, William F. Pierce, Richard Pazdur, Paul G. Kluetz, Laleh Amiri‐Kordestani, Michael Pacanowski, C S Lee, Sundeep Agrawal, Tiffany K. Ricks, Elizabeth Everhart, Adriene King-Ducre
article en
3 citations

Abstract

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.

Clinical Cancer ResearchVol. 30(24)
United States Food and Drug Administration (US), Center for Drug Evaluation and Research (US)
U.S. Department of Health and Human Services, American Association for Cancer Research, U.S. Food and Drug Administration, Genentech
Partnerships for the goals
Openalex Percentile: Top 22%
Colorectal Cancer Treatments and Studies
0.85
DOIOpen Access PDFOpenAlex
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