Novartis AG has been granted the U.S. Food and Drug Administration's regular approval for its drug combination to treat an aggressive form of skin cancer, Reuters reports.
The regulatory nod is based on two years of overall patient survival.
The FDA approved the combination of the drugs named Tafinlar and Mekinist for treatment of metastatic melanoma. These two drugs are among cancer drugs Novartis had purchased from GlaxoSmithKline Plc last year.
"We're inspired by the difference Tafinlar + Mekinist can make for patients battling such a serious disease," said Novartis president Bruno Strigini in an official statement, according to Tech Times.
The drug combination was initially approved last year based on mid-stage data through the FDA's accelerated approval program. However the complete approval was based on late stage trial data.
The combination, however, may cause serious side effects.
"Patients should be advised to contact their doctor immediately for a new wart, skin sore or bump that bleeds or does not heal, or a change in the size or color of a mole," warned the Novartis statement on top of other safety guidelines, according to Tech Times.
According to the pharmaceutical company, over 5,000 patients were part of clinical trials for the combination.
