Posted by Michael Wonder on 25 Mar 2020
Tepmetko (tepotinib) approved in Japan for advanced NSCLC with METex14 skipping alterations
25 March 2020 - TEPMETKO (Tepotinib) Approved in Japan for Advanced NSCLC with METex14 Skipping Alterations.
Merck today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tepmetko (tepotinib) for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations.
Tepmetko is administered 500 mg once daily as two 250 mg tablets. This is the first regulatory approval globally for an oral MET inhibitor indicated for the treatment of advanced NSCLC harbouring MET gene alterations. Tepmetko was previously granted SAKIGAKE ’fast-track’ designation and orphan drug designation by the MHLW.
