FDA Approves Merck KGaA's Tepmetko for Aggressive Lung Cancer

The U.S. Food and Drug Administration (FDA) granted Merck KGaA, Darmstadt, Germany’s Tepmetko (tepotinib) approval for adults with metastatic non-small cell lung cancer (NSCLC) who have a MET exon 14 skipping alteration. The drug was approved via the FDA’s Real-time Oncology Review program, in addition to Project Orbis, which allows for concurrent review by multiple regulatory agencies.