FDA has approved two drugs to GlaxoSmithKline for the treatment of advanced melanoma - the most aggressive skin cancer patients with specific genetic mutations. Regulatory approvals, and diagnostic test for demonstrating these mutations.
The drugs are approved for administration separately, once in two separate clinical trials, they showed delayed tumor growth.
After decades of virtually no progress in the fight against advanced melanoma, two new drugs celebrated turn in favor of medicine. Over the past two years, FDA has approved a total of 4 new drugs this indication.
Each year in the U.S. from melanoma ill about 75 000 people. The mortality rate is around 9,000 to 10,000 per year.
Forecast sales for each of the two new drugs are about 350 million dollars a year.