Tepotinib, the first FDA-approved treatment for MET-mutated lung cancer, improves tumor shrinkage and survival.

Patients diagnosed with specific types of metastatic non-small cell lung cancer (NSCLC) will have continued access to tepotinib (Tepmetko) following the U.S. Food and Drug Administration’s (FDA) regular approval of the oral medication.

The agency announced on Feb. 15 that tepotinib was granted full approval for treating adults with NSCLC who harbor MET exon 14 skipping alterations. These alterations are not as common as other subtypes, such as EGFR mutations or ALK arrangements, but are present in some 3% to 4% of patients with NSCLC.

Regulators previously granted accelerated approval for tepotinib in 2021. The treatment also received approval in the European Union for adults with NSCLC harboring MET Exon 14 skipping mutations in 2022.

“The approval of [tepotinib] provides a much-needed targeted treatment option for patients with advanced non-small cell lung cancer with METex14 skipping alterations,” said Egbert Smit, PhD, a VISION study investigator at the Netherlands Cancer Institute in a 2022 news release by drugmaker EMD Serono. “[Tepotinib] has demonstrated durable and consistent response rates and has the potential to help patients with this challenging cancer.”

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