FDA grants traditional approval for Merck’s Tepmetko

The US Food and Drug Administration yesterday revealed it has granted traditional approval for Tepmetko (tepotinib,) from EMD Serono, a US subsidiary of Germany’s Merck KGaA (MRK: DE), for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

Tepotinib was previously granted accelerated approval for this indication on February 3, 2021, based on initial overall response rate (ORR) and duration of response (DOR) in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study. The conversion to traditional approval was based on an additional 161 patients and an added 28 months of follow-up time to assess DOR.

In competition with Novartis’ Tabrecta