EMD Serono’s MET Inhibitor Nabs Accelerated Approval for Nonsmall-Cell Lung Cancer

The FDA has granted accelerated approval for EMD Serono’s oral MET inhibitor Tepmetko (tepotinib) for metastatic nonsmall-cell lung cancer (NSCLC) with certain alterations.

After conducting its priority review, the agency decided to approve the drug for adults with metastatic NSCLC who have mesenchymal-epithelial transition exon 14 (METex14) skipping alterations. The approval was granted based on the overall response rate and duration seen in phase 2 trial participants.

The FDA noted, however, that its continued approval may hinge on verifying and describing the drug’s clinical benefit in confirmatory trials. NSCLC with METex14 skipping alterations, an aggressive lung cancer, is seen in approximately 3 percent to 4 percent of NSCLC cases.