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FDA accepts Merck KGaA tepotinib application for lung cancer

August 25, 2020

Under Priority Review status, the FDA accepts for review Merck KGaA (OTCPK:MKGAY) unit EMD Serono’s marketing application seeking approval of tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a certain mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping, an aggressive type of NSCLC with a poor prognosis. It is a Breakthrough Therapy-tagged indication.

Tepotinib is a small molecule inhibitor of an enzyme called c-Met receptor tyrosine kinase. C-Met signaling is associated with aggressive treatment-resistant cancer.

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