Novartis edges Roche in targeted melanoma with Tafinlar-Mekinist adjuvant 'breakthrough'

Novartis' Tafinlar-Mekinist combo bears targeted approvals in melanoma and lung cancer.

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.

RELATED: The top 15 best-selling cancer drugs in 2022

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

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.

RELATED: Novartis picks up FDA approval for targeted lung cancer meds Tafinlar, Mekinist

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.

Suggested Articles

Look out, diabetes market: Novo Nordisk won its FDA nod for highly anticipated Rybelsus to control blood sugar in patients with Type 2 diabetes.

Insys is in fire sale mode as part of its bankruptcy plan, and now it’s been given the go-ahead to sell the opioid that helped get it there.

GSK CEO Emma Walmsley could soon have a new title: Microsoft board member. The software giant has nominated her to its board of directors.