Japan first to fast track Merck KGaA's tepotinib

27 March 2018

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.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK