Novartis gets FDA breakthrough status for Tafinlar, Mekinist combination

FILE PHOTO - A Novartis logo is pictured on its headquarters building in Mumbai April 1, 2013. REUTERS/Vivek Prakash/File Photo

ZURICH (Reuters) - Novartis on Monday said the U.S. Food and Drug Administration has granted breakthrough therapy status to the combination of Tafinlar and Mekinist to treat patients with BRAF V600-positive stage III melanoma following surgery. "There is a need for more effective treatment options for stage III melanoma patients at a high risk of recurrence following surgical resection," Samit Hirawat, head of global drug development at Novartis' oncology unit, said in a release. "We thank the FDA for recognizing the scientific advancement Tafinlar and Mekinist may provide in this adjuvant setting." (Reporting by Brenna Hughes Neghaiwi; Editing by Vyas Mohan)