The US Food and Drug Administration (FDA) has approved vemurafenib (Zelboraf, Genentech, a member of the Roche Group) for metastatic or unresectable melanoma. Vemurafenib, a BRAF inhibitor, is able to block the function of the V600E-mutated BRAF protein.
Vemurafenib is indicated only for patients with melanoma which expresses the BRAF V600E mutation. The drug has not been studied in patients whose melanoma tests negative for that mutation. Therefore, vemurafenib has been approved in conjunction with a first-of-a-kind diagnostic test, the Cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems).
Approved under the FDA’s priority review program, vemurafenib has been approved with a Medication Guide to inform healthcare professionals and patients of potential risks.
Vemurafenib was approved based on a single international trial of 675 chemotherapy-naïve patients with late-stage melanoma with the BRAF V600E mutation who were randomized to vemurafenib or dacarbazine. Median survival has not been reached (77% still living) in the vemurafenib group and was 8 months (64% still living) in the dacarbazine group. Approval of the Cobas 4800 BRAF V600 Mutation Test was based on data from the same study, which collected melanoma tissue samples from patients and tested them for the mutation.
The most common side effects reported with vemurafenib included joint pain, rash, hair loss, fatigue, nausea, and skin sensitivity when exposed to the sun. About 26% of patients developed a cutaneous squamous cell carcinoma, which was managed with surgery.
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