Roche Seeks Regulatory Approval for Aggressive Skin Cancer Medicine

Roche Holding AG (ROG) asked U.S. and European health regulators to approve its vemurafenib drug as a treatment for the most aggressive and deadly form of skin cancer.

Roche asked the U.S. Food and Drug Administration and the European Medicines Agency to grant marketing permission for the treatment as a therapy for melanoma that has spread, the Basel, Switzerland-based company said today in an e-mailed statement. The drugmaker also filed for approval for a diagnostic test that would identify patients likely to benefit from the medicine.

Roche said Jan. 19 that vemurafenib, designed to treat patients who carry a gene mutation called BRAF V600, helped them live longer and curbed the growth of the cancer in a study. The Swiss company is developing the medicine with Plexxikon Inc., a U.S. biotechnology company. About 40,000 people die from metastatic melanoma each year, according to Roche.

“We have worked swiftly to advance the vemurafenib development program knowing that patients with metastatic melanoma have a poor prognosis and limited treatment options,” Hal Barron, Roche’s head of product development, said in the statement.

Serious side effects of the medicine were a more common and treatable skin cancer and changes in the levels of liver enzymes. The most common side effects were rash, light sensitivity, joint pain, hair loss and fatigue.

The number of patients with melanoma is expected to double in developed countries to 227,000 in 2019, according to Datamonitor Plc.

To contact the reporter on this story: Dermot Doherty in Geneva at ddoherty9@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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