EC approves Tepmetko for patients with advanced NSCLC with MET mutations

German life sciences and pharma company Merck KGaA (MRK: DE) late on Friday revealed that the European Commission (EC) has approved once-daily oral Tepmetko (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

The EC authorization comes around a year after the drug was cleared for this same indication by the US Food and Drug Administration, and nearly two years after its approval in Japan in March 2020.

“The approval of Tepmetko provides a much-needed targeted treatment option for patients with advanced non-small cell lung cancer with METex14 skipping alterations,” said Professor Egbert Smit, a VISION study investigator at the Netherlands Cancer Institute. “Tepmetko has demonstrated durable and consistent response rates and has the potential to significantly help patients with this challenging cancer,” he noted.