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Genentech’s Xeloda Is First Label Updated Under OCE’s ‘Project Renewal’

 
• By Kate Rawson

Capecitabine’s existing indications were revised and new indications added, reflecting uses that long have been considered standard of care; however, the cancer drug's label had been frozen in time since the approval of generics.

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No longer frozen in time, Xeloda's labeling has gotten some big changes. • Source: Shutterstock

The FDA’s Oncology Center of Excellence has completed the first “Project Renewal” update to the labeling of an older generic cancer drug with additional indications and dosing regimens for Genentech, Inc.’s Xeloda (capecitabine).

In 2018, officials began discussing the need to update the labeling of older, commonly prescribed oncology drugs to ensure they reflect current practice. The initial goal was to update five labels per year. In 2020, OCE said it had commenced work on the first two labels

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Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

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US FDA Advisory Committee Misperceptions Abound … At HHS

 
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US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
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