The FDA granted breakthrough therapy designation to Novartis' melanoma treatment, a combination of its Tafinlar and Mekinist drugs.
Here are three things to know.
1. Novartis received the designation after a third phase trial showed the three-year relapse-free survival rate for patients treated with the combination of drugs was 58 percent, compared to a 39 percent survival rate for patients that received a placebo.
2. Breakthrough therapy designation is given to treatments that treat a serious life threatening disease and demonstrate substantial improvement over existing therapies, according to the FDA website.
3. The combination of Tafinlar and Mekinist drugs is used to treat patients with stage-three skin cancer after surgical removal.