FDA grants 'Breakthrough' designation for tepotinib

The US Food and Drug Administration has granted Breakthrough Therapy designation for the investigational targeted therapy tepotinib in patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy, according to the drug’s developer, Germany’s Merck KGaA (MRK: DE).

Tepotinib is the third drug against this rare and aggressive sub-type of the disease to receive the coveted ‘Breakthrough status. Last week, Novartis (NOVN: VX) gained the tag for its capmatinib (INC280) and, previously, Pfizer's (NYSE: PFE) Xalkori (crizotinib) drug was granted the designation in 2018.

“Tepotinib was associated with robust objective responses with durability that has not previously been seen in patients with metastatic NSCLC harboring MET exon 14 skipping alterations, selected by either tissue or liquid biopsy approaches,” said Luciano Rossetti, global head of R&D for the Biopharma business of Merck. “This breakthrough therapy designation further underscores the potential of tepotinib, and we aim to advance this program and deliver this medicine as quickly as possible to NSCLC patients who may benefit,” he added.