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Pharmaceuticals / Regulatory Affairs

FDA Adds Rare Blood Disease Indication for Zelboraf

Nov. 8, 2017
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The FDA expanded the approval for Hoffman-Roche’s blood-cancer drug Zelboraf (vemurafenib) to include treatment for certain adults with Erdheim-Chester disease.

The indication applies to patients whose cancer cells harbor the BRAF V600 genetic mutation. Zelboraf was first approved in 2011 for patients with BRAF V600E melanoma.

The BRAF V600 mutation shows up in about half of the patients with Erdheim-Chester disease. Zelboraf is the first treatment for the disease approved by the FDA.

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