'Project Renewal': FDA updates older Genentech cancer drug label
The FDA today said it approved updated labeling for Roche’s cancer drug Xeloda (capecitabine) tablets as part of a pilot project that aims to ensure older cancer drug labels stay current with clinical practice.
The pilot, known as Project Renewal, was first announced by the FDA’s Oncology Center of Excellence (OCE) in 2018, with plans to update about 40 generic chemo labels that are still in use but no longer have brand name reference products so their labels may be out-of-date. The idea behind Project Renewal is to ensure these labels stay current and appropriately reflect how the drugs are used.
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