FDA approves Roche skin cancer drug Zelboraf

The logo of the Swiss drugmaker Roche is seen on a factory in Burgdorf near Bern November 17, 2010.

WASHINGTON (Reuters) - U.S. drug regulators on Wednesday approved a targeted skin cancer drug from Roche Holding along with its diagnostic test, an advance in personalized health care.

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.

Reuters reported on August 10 that an early nod for the drug, being developed in partnership with Daiichi Sankyo, was likely.

Roche shares rose 1.8 percent on the Swiss stock exchange to 133.9 Swiss francs.

Analysts have forecast annual Zelboraf sales for Roche of $732 million by 2015. And Vontobel analyst Andrew Weiss sees peak sales of 1.2 billion Swiss francs ($1.5 billion).

"Today's approval of Zelboraf and the (companion) 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, head of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety.

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.

Roche's Genentech unit, which will market the cancer drug in the United States, declined to comment on price when asked last week.

The diagnostic test will cost around $150, according to Paul Brown, president of Roche Diagnostics.

The company estimates that around 9,500 of the 70,000 new cases of melanoma expected to be diagnosed in the United States this year will be advanced forms of the skin cancer, with the BRAF mutation found in about half of all melanoma cases.

"The FDA approval of Zelboraf marks a major step forward in personalizing the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options," said Dr. Hal Barron, chief medical officer and head of global product development at Genentech.

The medicine is the first new oncology product from Genentech since 2004's launch of lung cancer drug Tarceva.

In late April, the FDA approved Johnson and Johnson's prostate cancer drug Zytiga also about two months before the scheduled deadline.

(Reporting by Anna Yukhananov. additional reporting by Katie Reid; editing by Michele Gershberg, Dave Zimmerman)