FDA Grants Accelerated Approval to Novartis’ Tafinlar and Mekinist Combination

The FDA has granted accelerated approval to Novartis’ oral combination treatment Tafinlar (dabrafenib) and Mekinist (trametinib) for adult and pediatric patients six years and older with unresectable or metastatic solid tumors with the BRAF V600E mutation that have progressed following prior treatment and who have no other feasible treatment options.

The accelerated approval expands the list of indications for the combination treatment in the U.S., which include various cancers with the BRAF V600E mutation. The mutations are linked to tumor growth in multiple cancers including thyroid, brain and gynecologic cancers.

The accelerated approval was supported by positive results from three clinical trials in which the combination treatment led to overall response rates of up to 80 percent.

The FDA grants accelerated approvals on condition that the sponsor follows up with postmarket studies to confirm the treatment’s efficacy and safety.