FDA approves Roche skin cancer drug Zelboraf

The diagnostic test of Roche Holding has also been approved by the authorities.The Food and Drug Administration was two months ahead of schedule in approving the drug, under the brand name Zelboraf, along with a companion diagnostic that identifies which patients have a specific genetic mutation that means they will benefit from the treatment.Zelboraf offers a treatment for patients who had few options in the past. In March, the FDA approved the first treatment to help patients with advanced melanoma live longer. The drug Yervoy, or ipilimumab, is sold by Bristol-Myers Squibb.Roche and Bristol have also agreed to collaborate on a novel clinical trial to see if the two melanoma drugs are safe and effective if taken together, potentially allowing them to be prescribed as a drug cocktail.About half of all melanomas, the deadliest form of skin cancer, have the genetic aberration the drug targets. Roche filed for U.S. approval of the drug in April and the FDA had to make a decision by October 28.The FDA said in July that targeted drugs would have to be reviewed at the same time as the diagnostic devices they rely on.The Roche drug, known clinically as vemurafenib, is designed for patients with tumors that have a mutation in a gene known as BRAF that allows melanoma cells to grow.A pivotal trial found that advanced melanoma patients taking the experimental pill were 63 percent less likely to die from the disease than patients given chemotherapy.The medicine is the first new oncology product from Genentech since 2004s launch of lung cancer drug Tarceva.In late April, the FDA approved Johnson and Johnsons prostate cancer drug Zytiga also about two months before the scheduled deadline.