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Novartis' targeted lung cancer combo picks up EU approval (Regulatory)

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CREDIT: This post was originally published on this site

With a new green light in Europe, Novartis just took another step in expanding the market for its targeted Tafinlar-plus-Mekinist combination therapy.

The duo notched regulatory approval to treat lung cancer associated with a particular genetic mutation, BRAF V600, in patients with advanced disease. It’s the first therapy specifically approved for this group of patients, who’ve previously had few treatment options, Novartis said.

About 1% to 3% of lung cancer patients worldwide have BRAF V600-positive advanced NSCLC. About 36,000 new cases are diagnosed each year, according to the World Health Organization.

That’s a small patient pool, but the combo is in line for a potential FDA approval later this year as well. All told, sales in the indication are expected to hit $318 million for Tafinlar and $278 million for Mekinist by 2025, according to GlobalData analysts. Together, the two drugs brought in $672 million last year.

Picked up in Novartis’ massive asset swap with GlaxoSmithKline, Tafinlar and Mekinist won their initial approvals to treat BRAF-positive advanced melanoma. In that disease type, the drugs compete with Roche’s BRAF-targeted Zelboraf and Cotellic. Tafinlar targets the BRAF mutation, while Mekinist is a MEK inhibitor with a complementary mechanism of action.

RELATED: Novartis heads to FDA after lung cancer combo clears pivotal trial

Novartis oncology head Bruno Strigini said in a statement the European Commission’s decision “represents an important milestone” for lung cancer patients, especially those affected by the mutation. In a phase 2 trial, Novartis’ combo showed a 61.1% overall response rate in previously untreated patients, with 68% percent experiencing no disease progression after nine months.

Earlier this year, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval based on that data.

RELATED: Novartis divides pharma unit in two as division chief Epstein makes an exit

Novartis’ drug combo is also under review at the FDA, late last year winning a priority review from the agency. FDA granted the combo a breakthrough therapy designation back in 2015.

The Swiss drugmaker made waves in the industry last year when it split up its drug business into two units, pharmaceuticals and oncology, naming Strigini to lead the latter group. The company has been working to expand in cancer drugs—as its big asset swap with GlaxoSmithKline illustrated—and recently filed its FDA application for an immuno-oncology treatment, the CAR-T drug CTL019. Novartis recently reorganized its CAR-T unit, but remains in a close race with Kite Pharmaceuticals for the first FDA nod in that field.

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