FDA approves Skin Cancer drug Zelboraf and companion diagnostic test for late-stage skin cancer.

The Food and Drug Administration approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

Zelboraf is specifically indicated for treatment of patients with melanoma tumors with gene mutation expression BRAF V600E. This drug approved with first of its kind test called cobas 4800 BRAF V600 Mutation test, a diagnostic test that will help determine if a patient's melanoma cells have the BRAF V600E mutation.

The BRAF protein is normally involved in regulating cell growth, but has been found to be mutated in about half of the patient with late-stage melanomas. Zelboraf is a BRAF inhibitor that is able to block the function of the V600e-mutated BRAF protein.

In a trial of 675 patients with late-stage melanoma with BRAF V600e mutation who had not received prior therapy. Patients were given Zelboraf to measure overall survival. The median survival (length of time a patient lives after treatment) of patients receiving Zelboraf has not been reached because 77 percent of the participants are still living

"Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research."

"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, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health."

The Cobas 4800 BRAF V600 Mutation Test was based on data from the clinical study that evaluated the safety and effectiveness of Zelboraf.

The most common side effects reported in patients receiving Zelboraf included joint pain, rash, hair loss, fatigue, nausea, and skin sensitivity when exposed to the sun. About 26 percent of the patients developed a skin-related cancer called cutaneous squamous cell carcinoma, which was managed with surgery. Patients treated with Zaelboraf should avoid sun exposure.

Zelboraf is being approved with a medication guide to inform health care professionals and patients of Zelboraf's potential risks.

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