Merck, a leading science and technology company, 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 harboring MET gene alterations. TEPMETKO was previously granted SAKIGAKE ’fast-track’ designation and orphan drug designation by the MHLW.
“With TEPMETKO, we are pleased to offer the first approved MET inhibitor in Japan, and a new option that can change the course of treatment for non-small cell lung cancer harboring METex14 skipping alterations,” said Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck. “With a focus on identifying these alterations in NSCLC patients with flexibility and precision, the companion diagnostic to TEPMETKO offers both liquid and tissue biopsy testing capabilities to best support the delivery of this targeted therapy to the patients who may benefit.”
The approval of TEPMETKO (tepotinib) in Japan is supported by data from 99 patients (including 15 Japanese patients) with NSCLC with METex14 skipping alterations enrolled in the ongoing single-arm Phase II VISION study.
Merck has a strategic partnership with ArcherDX to develop a companion diagnostic featuring both liquid and tissue biopsy capabilities to identify METex14 skipping alterations among patients with NSCLC with high precision and accuracy prior to treatment. The companion diagnostic received approval by MHLW in March 2020, and it is the first and only companion diagnostic to be approved for the detection of MET gene alterations.
In September 2019, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy. Merck plans to file tepotinib for regulatory review with the FDA in 2020.