The FDA has approved Zelboraf (vemurafenib tablets; Genentech and Plexxikon) for the treatment of metastatic or unresectable melanoma in patients whose tumors express the BRAF V600E gene mutation. A companion diagnostic test, the cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems) has been approved to help determine if a patient’s melanoma cells have the BRAF V600E mutation. Zelboraf was reviewed under the FDA’s expedited six-month priority review program.

The approvals of Zelboraf and the cobas 4800 BRAF V600 Mutation Test were based on data from BRIM3, a Phase 3, international, randomized, open-label, controlled, multicenter trial of 675 patients with late-stage melanoma with the BRAF V600E mutation who had not received prior therapy. Patients were assigned to receive either Zelboraf or dacarbazine. The trial was designed to measure overall survival. The median survival of patients receiving Zelboraf has not been reached (77% still living) while the median survival for those who received dacarbazine was 8 months (64% still living).

Zelboraf, an oral, small molecule, kinase inhibitor, will be available in a 240mg dosage strength tablet.

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