FDA OKs Novartis’ Tabrecta for certain lung cancer patients

Incyte (INCY -1.9%) announces that the FDA has approved exclusive licensee Novartis’ (NVS +1.2%) Tabrecta (capmatinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. The nod applies to a first-line setting as well as previously treated patients regardless of prior treatment type.

The approval triggers a $70M milestone payment to Incyte who will also receive 12-14% royalties on net sales.

METex14 occurs in 3-4% of newly diagnosed NSCLC cases. Capmatinib, an oral MET inhibitor, is the first such drug approved in the U.S. for these patients.

https://seekingalpha.com/news/3570367-fda-oks-novartis-tabrecta-for-certain-lung-cancer-patients