Germany’s Merck KGaA (MRK: DE) has won Japanese approval for Tepmetko (tepotinib), for the treatment of certain people with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC).
The drug is used to treat people with MET exon 14 (METex14) skipping alterations. It is the first regulatory approval for an oral MET inhibitor for the treatment of advanced NSCLC, harboring MET gene alterations.
The therapy was granted Fast Track designation and Orphan Drug designation by the Japanese Ministry of Health, Labor and Welfare (MHLW).
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