Accelerated approval from FDA for tepotinib in metastatic NSCLC

The US Food and Drug Administration late yesterday granted accelerated approval to Tepmetko (tepotinib), from EMD Serono, the US healthcare business 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.

“This approval of Tepmetko by the FDA is an important milestone on our mission to significantly improve the treatment of cancer where MET plays a driving role,” said Dr Danny Bar-Zohar, global head of development for the Healthcare business sector of Merck, adding: “Our focus now is to ensure Tepmetko is accessible to patients in the United States and fully integrated into clinical practice given the important advance it represents for indicated patients as an oral once-a-day precision medicine.”

Tepmetko is the first and only FDA approved MET inhibitor that offers once-daily oral dosing and is administered as two 225mg tablets (450mg). Patients with metastatic NSCLC should be selected for treatment with Tepmetko based on the presence of MET exon 14 skipping alterations.