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Merck KGaA Announces Orphan Drug Designation For Tepotinib In Japan

Merck KGaA said that the Japanese Ministry of Health, Labour and Welfare has granted orphan drug designation for its investigational therapy tepotinib for patients with non-small cell lung cancer or NSCLC harboring MET gene alterations.

The Japanese Ministry of Health, Labour and Welfare grants orphan drug designation for diseases that affect fewer than 50,000 patients in Japan, and for which significant unmet medical need exists.

Tepotinib is also being investigated in the INSIGHT 2 study (NCT03940703) in combination with the tyrosine kinase inhibitor (TKI) osimertinib in epidermal growth factor receptor (EGFR) mutated, MET amplified, locally advanced or metastatic NSCLC having acquired resistance to prior EGFR TKI.

In March 2018, tepotinib received SAKIGAKE 'fast-track' regulatory designation in Japan and in September 2019 received Breakthrough Therapy Designation in the U.S.

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