Score one for Novartis in its quest to expand its cancer-fighting combo, Tafinlar and Mekinist.
On Monday, the FDA bestowed its “breakthrough” tag on the pair in adjuvant, BRAF V600 mutation-positive melanoma, setting it up for a quick trip down the regulatory path to approval. The agency’s decision to do so comes on the back of phase 3 data that showed the Novartis tandem could bring the three-year relapse-free survival rate to 58% of patients, versus just 39% with placebo.
If Novartis can snag a regulatory go-ahead, its duo will become the first adjuvant treatment specifically for BRAF V600 patients. And the Swiss drugmaker will also get a leg up on its crosstown rival, Roche, whose Cotellic-Zelboraf combo competes against Tafinlar and Mekinist in BRAF-positive melanoma that has spread to other parts of the body or can’t be surgically removed.
That’s not to say Roche isn’t working on upping its own melanoma game. It’s trialling Cotellic and Zelboraf in a cocktail with PD-L1 medication Tecentriq as a first-line treatment for BRAF V600 melanoma, and it expects to file that trio—currently in phase 3—for approval in 2019.
Meanwhile, Novartis is working to build up Tafinlar and Mekinist—acquired in 2015’s blockbuster three-part transaction with GlaxoSmithKline—beyond melanoma, too. In June, the company picked up an FDA green-light for the combo in metastatic non-small cell lung cancer patients with the BRAF V600E mutation based on phase 2 study results showing that more than 60% of treatment-naive and previously treated patients responded to the treatment.