Japan first to fast track Merck KGaA's tepotinib
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted SAKIGAKE ’fast-track’ designation for Merck KGaA’s (MRK: DE) tepotinib for patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations.
SAKIGAKE designation is the Japanese system of selecting promising drugs and making them available to patients in Japan ahead of the rest of the world. It can reduce a candidate’s review period down from a year to a target of six months.
The designation consultation on the clinical development program for tepotinib includes a Phase II study exploring the potential of this small molecule in patients with advanced NSCLC harboring MET exon 14 skipping mutations – a population that currently has no approved therapies available.
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