(Reuters) – The U.S. Food and Drug Administration (FDA) said on Wednesday it had approved Array BioPharma Inc’s oral combination treatment for use in patients with the deadliest form of skin cancer.
The combination therapy, which consists of encorafenib and binimetinib, is approved bit.ly/2tNoOQW to treat patients with advanced melanoma associated with a common gene mutation called a BRAF mutation, the FDA said.
Shares of Array BioPharma were halted in afternoon trading.
The company released data from a key trial in February that showed the combination led to median overall survival of 33.6 months, meaning half the patients were still alive nearly three years after the treatment.
This was in comparison to a median overall survival of 16.9 months observed in patients in the control arm of the study, who were administered Roche Holding AG’s Zelboraf, a drug that is commonly part of standard-of-care regimens.
The combination, dosed as 450 milligrams of encorafenib once daily and 45 mg of binimetinib twice a day, gives Array its first marketable regimen.
About 91,270 new melanomas will be diagnosed and about 9,320 people are expected to die of melanoma in the United States in 2018, according to the American Cancer Society.
(The story was refiled to correct the third paragraph to clarify that shares were halted and not up 2.2 percent)
Reporting by Tamara Mathias and Anuron Kumar Mitra in Bengaluru; Editing by Anil D’Silva