Novartis receives FDA regular approval for Tafinlar + Mekinist for Melanoma

November 22, 2015

The FDA granted regular approval for the combination of Tafinlar® (dabrafenib) + Mekinist® (trametinib) from Novartis for the treatment of patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. This is the first targeted therapy combination demonstrating more than two years overall survival in patients with the most aggressive form of skin cancer.

"We're inspired by the difference Tafinlar + Mekinist can make for patients battling such a serious disease as metastatic melanoma," said Bruno Strigini, President, Novartis Oncology. "This approval of the combination in the US allows us to communicate more broadly with the melanoma community about the role of targeted therapies, our data, the possibility to improve clinical outcomes for patients, and our commitment to develop these medicines to their fullest potential."

More than 5,000 patients have had experience with the combination use of Tafinlar + Mekinist in clinical trials and since its initial approval in 2014, the combination of Tafinlar + Mekinist has extended the lives of many patients with BRAF mutation-positive metastatic melanoma. Today's regular approval is based on survival data from two Phase III studies: COMBI-d and COMBI-v. These studies showed that Tafinlar + Mekinist demonstrated statistically significant progression-free survival (PFS) and overall survival (OS) compared with dabrafenib or vemurafenib, in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma.

The FDA granted priority review in July 2015 for approval of the Tafinlar + Mekinist combination in BRAF V600E/K mutation-positive unresectable or metastatic melanoma. Since January 2014, the combination of Tafinlar + Mekinist has been approved for use in the US in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. The combination was initially approved based on Phase II data through the FDA's Accelerated Approval program and reviewed under a priority review designation. The approval was contingent on the results of the Phase III COMBI-d study, which was designed to evaluate the clinical benefit of the combination in patients with unresectable or metastatic melanoma with a BRAF V600E/K mutation.

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