New Drug Cleared for Late-Stage Melanoma

A drug to treat late-stage or inoperable melanoma was approved today (Aug. 17) by the U.S. Food and Drug Administration.

The drug, Zelboraf, is the second melanoma drug approved this year that has been found to improve patients' overall survival, said Dr. Richard Pazdur, at the FDA's Center for Drug Evaluation and Research. Zelboraf is made by Roche.

The other drug, Yervoy, is made by Bristol-Meyers Squibb and was approved in March.

"This has been an important year for patients with late-stage melanoma," Pazdur said.

Zelboraf is only approved for patients with melanoma whose tumors express a gene mutation called BRAF V600E . The drug has not been studied in patients whose melanoma doesn't have that mutation.

The drug blocks the function of the mutated BRAF protein in these patients.The BRAF protein is normally involved in regulating cell growth, but is mutated in about half of the patients with late-stage melanomas.

Zelborafhas been approved along with a first-of-a-kind diagnostic test called the cobas 4800 BRAF V600 Mutation Test. The test will help determine if a patient's melanoma cells have the BRAF V600E mutation.

"Today's 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," said Alberto Gutierrez, a director in the FDA's Center for Devices and Radiological Health.

Zelboraf was reviewed under the FDA's priority review program that 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's safety and effectiveness were established in a single, international trial of 675 patients who had late-stage melanoma with the BRAF V600E mutation who had not received prior therapy. Patients were assigned to receive either Zelboraf or dacarbazine, a chemotherapy drug that does not target any specific mutation and is a current standard treatment for these patients.

Seventy-seven percent of patients who received Zelborafare still living, while 64 percent of those who received dacarbazineare still alive.

Melanoma is the leading cause of death from skin disease. The National Cancer Institute estimated that 68,130 new cases of melanoma were diagnosed in the United States during 2010; about 8,700 people died from the disease.

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