Merck's MET Inhibitor Tepmetko Receives Positive Scientific Opinion from UK MHRA for METex14-Skipping Advanced NSCLC
Merck Group
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Medicines and Healthcare products Regulatory Agency
The MHRA is an executive agency of the UK Department of Health and Social Care, responsible for ensuring that medicines and medical devices work effectively and are safe and reliable. Established in 2003 through the merger of the Medicines Control Agency and the Medical Devices Agency, the organization employs more than 1,300 staff members.
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Recently, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive scientific opinion on Merck's targeted anticancer drug Tepmetko (tepotinib) for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations (METex14 skipping).
The MHRA’s positive scientific opinion has been published under the Early Access to Medicines Scheme (EAMS). The scheme aims to enable patients with serious conditions and significant unmet medical needs to access medicines that have not yet been granted marketing authorisation in the UK.
NSCLC is the most common type of lung cancer, accounting for 80–85% of diagnosed lung cancer cases. Among these cases, approximately 3–4% of patients harbor MET exon 14 skipping mutations, which are associated with a poorer clinical prognosis compared to other types of NSCLC.
Tepmetko is a highly selective MET inhibitor administered orally once daily. First approved in Japan in March 2020, it became the world's first oral MET inhibitor approved for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring MET gene alterations. In February this year, Tepmetko also received approval from the U.S. FDA.
Based on the Phase II trial results of the VISION study, the MHRA has approved a scientific opinion for Tepmetko. The study evaluated the efficacy and safety of Tepmetko as a monotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations. In this study, the objective response rate (ORR) with Tepmetko treatment reached 46%, as determined by independent assessment of the combined biopsy cohort (liquid biopsy + tissue biopsy).
Source: Merck’s MET inhibitor tepotinib gains positive opinion from MHRA
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