Priority Review for Novartis' Tafinlar plus Mekinist for melanoma

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA accepted and granted Priority Review to an sNDA for Tafinlar dabrafenib (GSK2118436) plus Mekinist trametinib as an adjuvant treatment for patients with stage III melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, following complete resection. The combination has breakthrough therapy designation in the indication. Novartis spokesperson Dana Cooper declined to give the PDUFA date.

Mekinist is a small molecule inhibitor of MAP kinase kinase 1 (MAP2K1; MEK1) and MAP2K2 (MEK2), and Tafinlar is an oral BRAF protein kinase inhibitor. The drugs are approved in the U.S. and EU as a combination and as monotherapies to treat unresectable or metastatic BRAF V600 mutation-positive melanoma. The combo is also approved in the U.S. to treat metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC), and in the EU to treat advanced BRAF V600 mutation-positive NSCLC...