United States: the drug agency approves Roche Zelboraf for melanoma

Written by Sandeep Nehra

The U.S. Agency for Drug Administration (FDA) announced on Wednesday it had approved the marketing of the laboratory Zelboraf Helvetic Roche to treat melanoma – skin cancer the most serious – advanced or inoperable.

This is the second treatment authorized this year by the FDA (Food and Drug Administration) for melanoma, to prolong patient survival.

The Zelboraf (vemurafenib), administered orally, neutralizes the mutant gene BRAF V600E to prevent it from producing a protein that plays a key role in the development of this cancer.

About half of patients with metastatic melanoma are carriers of this genetic mutation.

The FDA has also approved the Zelboraf a test called “cobas 4800 BRAF V600 Mutation Test” to diagnose patients with mutant BRAF gene.

An international clinical trial Phase 3, the results were presented at the 47th annual conference of the American Society of Clinical Oncology (ASCO) in Chicago in early June, showed that the vemurafenib reduced by 63% the risk of death in patients with Zelboraf took from those undergoing chemotherapy.

The vemurafenib also allowed a 74% reduction in the risk of disease progression compared to dacarbazine, anti-cancer agent used in chemotherapy for cancer.

The median survival of patients undergoing this treatment has not been arrested since 77% of them are still alive. Patients treated with dacarbazine showed a median survival of eight months, said FDA in a statement.

For this trial, 675 patients suffering from metastatic melanoma who have never been treated and are all holders of the BRAF mutations were selected. Half were treated with vemurafenib and the other half with conventional chemotherapy.

Less than 10% of participants treated with vemurafenib suffered side effects including skin irritation and joint pain.

“2011 was an important year for patients suffering from advanced melanoma with the marketing of two new anti-cancer,” said Dr. Richard Pazdur, director of the Office of Evaluation and Research of anti- cancer.

In March, the FDA had approved the Yervoy (ipilimumab), an antibody Laboratory Bristol-Myers Squibb, which stimulates the immune system.

The Yervoy was the first drug to show a substantial improvement in survival in patients with a melanoma in a Phase 3 clinical trial announced at the ASCO conference in 2010.

The next step is to test a combination of the antibody with the Yervoy vemurafenib in patients with advanced melanoma.

A clinical trial of Phase 1, approved by the FDA, has already begun.

According to the World Health Organization, the skin cancer is responsible for 66,000 deaths a year worldwide, about 80% of melanomas. More than half of those in whom was diagnosed with melanoma are under 59 years.