The FDA has approved tepotinib (capmatinib) for the treatment of metastatic non-small cell lung canc

On May 6, 2020, Novartis announced today that the U.S. Food and Drug Administration (FDA) has approved Tepotinib™ (Capmatinib, formerly known as INC280), an oral MET inhibitor, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor MET exon 14 skipping mutations (METex14) as confirmed by an FDA-approved test. This indication was granted accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.

This approval fills a long-standing and urgently unmet medical need — prior to this, there were no approved targeted therapies specifically directed against the driver gene of lung cancer in patients with NSCLC harboring MET exon 14 skipping mutations. Tepotinib is approved for both first-line treatment and use in previously treated patients, regardless of prior treatment type, and is expected to be available to patients within the next few days.

The FDA also approved FoundationOne®CDx as a companion diagnostic for Tepotinib, to assist in detecting mutations that cause MET exon 14 skipping in tumor tissues.

"Non-small cell lung cancer is a complex disease with a variety of genetic mutations that can drive cancer progression," stated Dr. Jürgen Wolf, MD, of the Comprehensive Cancer Center at the University Hospital of Cologne and principal investigator of the GEOMETRY study. "MET exon 14 skipping mutation is a known oncogenic driver. With today’s FDA approval decision, we can now diagnose this difficult-to-treat lung cancer through testing and treat it with targeted therapy, bringing new hope to NSCLC patients harboring this mutation."

Novartis previously obtained Breakthrough Therapy Designation for Capmatinib. According to relevant FDA guidelines, a treatment designated as a breakthrough therapy must target a serious or life-threatening disease and demonstrate substantial improvement over existing therapies on one or more important preliminary clinical endpoints.

Tepotinib (Capmatinib) is a kinase inhibitor that targets MET. In 2009, Incyte Corporation licensed the drug to Novartis. Under the terms of the agreement, Incyte granted Novartis the exclusive global rights to develop and commercialize Capmatinib and certain backup compounds for all indications.