Novartis Therapy for Melanoma Receives Breakthrough Designation

The FDA granted Novartis breakthrough therapy designation for its adjuvant treatment of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for melanoma patients after surgery, the company said.

The therapy is indicated for patients with stage III melanoma with a BRAF V600 mutation following complete resection.

The FDA previously approved the combination for patients with unresectable or metastatic melanoma who have a BRAF V600 mutation and for those with metastatic non-small cell lung cancer with a BRAF V600E mutation.