Merck Receives Fast-Track Designation for Tepotinib in Non-Small Cell Lung Cancer in Japan

Food and Healthcare Press Releases Wednesday March 28, 2018 08:15
DARMSTADT, Germany--28 Mar--PRNewswire/InfoQuest
Not intended for UK- or US-based media
  • Japanese Ministry of Health, Labour and Welfare Grants SAKIGAKE designation for tepotinib, Merck's investigational highly selective c-Met receptor tyrosine kinase inhibitor
  • First regulatory designation for tepotinib
  • SAKIGAKE designation encompasses the possibility for a target review period of 6 months

Merck, a leading science and technology company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SAKIGAKE 'fast-track' designation for its investigational molecule tepotinib* for patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. SAKIGAKE designation promotes research and development in Japan, aiming at early practical application for innovative pharmaceutical products, medical devices, and regenerative medicines, and can reduce a drug's review period down from 12 months to a target of 6 months. This is the first regulatory designation granted to tepotinib.

"This fast-track designation in Japan recognizes the progress we are making with tepotinib as part of our strategic focus on delivering innovative precision medicines to oncology patients," said Luciano Rossetti, M.D., Global Head of Research & Development at the Biopharma business of Merck. "Tepotinib is a highly selective small molecule that - if supported by the outcome of further studies - may have the potential to provide particular benefit to NSCLC patients with this genetic mutation."

The SAKIGAKE Designation System is a core component of the MHLW's "Strategy of SAKIGAKE". The system's objective is to designate drugs that have the potential of prominent effectiveness against serious and life-threatening diseases in order to make them available to patients in Japan ahead of the rest of the world.

Tepotinib, discovered in-house at Merck, is an investigational inhibitor of the c-Met receptor tyrosine kinase. 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. Data from this study will be presented at an upcoming medical congress.

Merck's oncology and immuno-oncology pipeline includes high-quality, selective small molecules, antibodies and antibody-drug conjugates with strong translational research data supporting each drug's clinical development. In addition to tepotinib, the oncology pipeline includes M7824, an investigational bifunctional immunotherapy, designed to simultaneously block two immunoinhibitory pathways (programmed death ligand-1 and transforming growth factor-β), as well as a number of anti-DNA Damage Response molecules (including inhibitors of DNA-PK, ATR and ATM).

*Tepotinib is the recommended International Nonproprietary Name (INN) for the c-Met kinase inhibitor (MSC 2156119J). Tepotinib is currently under clinical investigation and not approved for any use anywhere in the world.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer (both small cell and non-small cell) has been the most common cancer in the world for several decades.[1] Globally, lung cancer is responsible for approximately 1 in every 5 deaths from cancer.[1] The five-year survival rate for people diagnosed with lung cancer that has spread (metastasized) to other areas of the body is 1%.[2] NSCLC is the most common type of lung cancer, accounting for 80 to 85% of all lung cancers.[2] MET Exon 14 skipping mutations occur in 2-3% of lung cancers.[3]

About Tepotinib

Tepotinib is an investigational, highly selective small-molecule inhibitor of the c-Met receptor tyrosine kinase. Alterations of the c-Met signaling pathway are found in various cancer types and correlate with aggressive tumor behavior and poor clinical prognosis. Tepotinib is being investigated in a Phase II study in non-small cell lung cancer.

About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2017, Merck generated sales of EUR 15.3 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to to register online, change your selection or discontinue this service.


1. International Agency for Research on Cancer (IARC). GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012; Lung Cancer. Available from: . Last accessed: March 2018.

2. Lung cancer - non-small cell: statistics. Available from: . Last accessed: March 2018.
3. Reungwetwattana T, Liang Y, et al. The race to target MET exon 14 skipping alterations in non-small cell lung cancer: The Why, the How, the Who, the Unknown, and the Inevitable. Lung Cancer. 2017;103:27-37.
(Logo: )
Source: Merck

Latest Press Release

The Menarini Group Announces Meropenem/vaborbactam European Marketing Authorization

- Meropenem/vaborbactam approved on 20th November 2018 by the European Commission for clinical use in adult patients with difficult-to-treat infections - The first combination of a carbapenem and a beta-lactamase inhibitor approved for clinical use in...

Merck Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer

- FDA grants M7824, an investigational bifunctional immunotherapy, orphan drug designation in biliary tract cancer - First regulatory designation for M7824 following recent presentation of first clinical data in BTC - BTC is a group of rare, aggressive...

Merck in Agreement With Cyclica for AI-augmented Screening Platform to Expand Research Capabilities

- Agreement to screen discovery and early development compounds using artificial intelligence and computational biophysics - Cloud-based in silico platform that screens small molecules to determine polypharmacological profiles - Evaluation to include...

Vitality-linked Insurers to Get 100 million People 20% More Active by 2025

Building on the results of the largest behaviour change study on physical activity, Vitality and its global network of insurers have collectively committed to improving the health of millions over the next seven years. This is in line with the World...

World Congress of Cardiology Cardiovascular Health 2018 Opens in Dubai

- Professor David Wood, President of the World Heart Federation, welcomes more than 5000 cardiologists, doctors, nurses, and health and policy experts from around the world to Dubai for WCC 2018 at a time when the opportunities for a sustainable impact...

Related Topics