Novartis gets FDA breakthrough status for Tafinlar, Mekinist combination

ZURICH: 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.”