The U.S. Food and Drug Administration has approved Zelboraf (vemurafenib), a drug to treat patients with late-stage or unresectable melanoma.
Zelboraf is specifically indicated for the treatment of patients with melanoma whose tumors express a gene mutation called BRAF V600E. The drug has not been studied by an FDA-approved diagnostic in patients whose melanoma tests negative for that mutation.
Zelboraf is being approved with a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic that will help determine whether a patient’s melanoma cells have the BRAF V600E mutation.
The BRAF protein is normally involved in regulating cell growth, but is mutated in about half of the patients with late-stage melanomas. Zelboraf is a BRAF inhibitor that is able to block the function of the V600E-mutated BRAF protein.
“This has been an important year for patients with late-stage melanoma,” Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in a news release.
“Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival. In March, we approved Yervoy (ipilimumab), another new treatment for late-stage melanoma that also showed patients live longer after receiving the drug.”
Zelboraf was reviewed under the FDA’s priority review program, which provides for an expedited six-month review of drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Zelboraf and the companion BRAF V600E test are being approved ahead of the drug’s Oct. 28 goal date and the companion diagnostics’ Nov. 12, goal date.
Zelboraf is marketed by South San Francisco based-Genentech, a member of the Roche Group. The cobas 4800 BRAF V600 Mutation Test is manufactured by Roche Molecular Systems in Pleasanton, Calif.