Zelboraf approved for melanoma

August 24, 2011

The Food and Drug Administration (FDA) has approved the oral targeted therapy vemurafenib (Zelboraf, Plexxikon/Roche) for treatment of metastatic and unresectable melanomas, Medscape Today reports.

Washington - The Food and Drug Administration (FDA) has approved the oral targeted therapy vemurafenib (Zelboraf, Plexxikon/Roche) for treatment of metastatic and unresectable melanomas, Medscape Today reports.

The drug earned approval under the FDA’s priority review program, which allows an expedited six-month process for therapies that may offer significant advances or provide a treatment when no adequate options exist.

Vemurafenib is specifically indicated for the estimated 50 percent of melanoma patients whose tumors have V600E mutations in the BRAF gene. The drug is not indicated for patients without the mutation. Vemurafenib is a BRAF inhibitor that blocks the function of the V600E-mutated protein.

Approved along with the drug is a diagnostic test, the cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems), which will help determine whether a patient's melanoma cells carry the BRAF V600E mutation.

Earlier this year the FDA proved Yervoy (ipilimumab, Bristol-Myers Squibb), another new treatment for late-stage melanoma that extends patients’ lifespans. Vemurafenib will be marketed differently, as it targets a more specific patient population.

Medscape Today quotes Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, as saying that the “approval of Zelboraf and the cobas test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner.”

The FDA’s approval of both the drug and the diagnostic test were based on a phase 3 trial in which patients receiving vemurafenib had a 74 percent reduction in the risk for progression (or death) compared with those who received the standard dacarbazine chemotherapy. After reviewing the trial’s interim results, an independent data and safety monitoring board recommended that patients being treated with dacarbazine be switched to vemurafenib.

The drug will be marketed in the United States by Genentech and Daiichi Sankyo, which secured rights to the drug in its acquisition of Plexxikon, the company that co-developed vemurafenib along with Roche.