Merck KGaA matches Novartis with FDA green light for targeted lung cancer drug Tepmetko

Tepmetko won its first global approval last March with a go-ahead in Japan. (Merck KGaA)

Novartis may have jumped out ahead of Merck KGaA with targeted lung cancer med Tabrecta, but the German drugmaker has evened the score.

The FDA Wednesday cleared its drug Tepmetko in non-small cell lung cancer patients with MET exon 14 skipping mutations, whether or not they’ve received prior treatments. The mutation affects about 3% to 4% of NSCLC patients and creates an aggressive form of the disease.

Tepmetko will bear a list price of $20,898.60 for a 30-day supply, which is "within the range of other oral oncolytics for advanced NSCLC," a spokesperson said by email.

U.S. regulators based their decision on data from the phase 2 Vision trial, which showed Tepmetko could spur a benefit in 43% of patients. Previously treated patients continued to respond to the drug for a median 11.1 months, while those new to therapy responded for a median 10.8 months.

RELATED: Merck KGaA beats out Novartis with targeted lung cancer nod for Tepmetko in Japan

The FDA’s nod follows up on a positive decision from the Japanese Ministry of Health, Labour and Welfare, which last March became the first global regulator to green-light a MET inhibitor. Since then, though, the FDA has gotten in on the action with its May 2020 go-ahead for Tabrecta, and now Merck will be taking its product toe-to-toe with Novartis’ in the U.S.

While the Swiss pharma giant has the head start, Merck KGaA has its own advantage to tout: once-daily dosing. Tabrecta tablets are given twice daily at a 400 mg dose, while patients take two 225 mg Tepmetko tablets simultaneously just once per day.

"Our focus now is to ensure Tepmetko is accessible to patients in the United States and fully integrated into clinical practice, given the important advance it represents for indicated patients as an oral once-a-day precision medicine,” said Danny Bar-Zohar, M.D., global head of development for Merck KGaA’s healthcare business.

RELATED: Novartis beats Merck KGaA to U.S. finish line with targeted lung cancer drug Tabrecta

To do that, though, first Merck KGaA will have to ramp up MET testing—a goal Novartis shares. Testing for the mutation is usually done as part of next-gen lung cancer sequencing, Ameet Mallik, EVP at Novartis Oncology U.S., said an interview last spring, and at that time, only about 35% of U.S. lung cancer patients were receiving that sequencing upfront.