{"entity":{"id":"tepotinib","kind":"drug","name":"Tepotinib","aka":["MSC2156119","EMD 1214063"],"tldr":"Tepotinib is a once-daily targeted pill for lung cancers driven by a MET exon 14 skipping mutation, and the MET inhibitor NICE funds in England.","summary":"Tepotinib is an oral MET inhibitor for advanced non-small cell lung cancer with MET exon 14 skipping alterations, which can be detected in tumour tissue or in circulating tumour DNA. The VISION trial showed durable responses in about half of patients whether or not they had been treated before. Japan approved it first in 2020, the FDA in 2021 and the EU in 2022. NICE recommended it in 2022 within its licence with a commercial arrangement. Peripheral oedema is the main side effect.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Tepotinib","links":[{"label":"VISION (NEJM 2020)","url":"https://doi.org/10.1056/NEJMoa2004407"},{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=tepotinib"},{"label":"NICE TA789: tepotinib for treating advanced non-small-cell lung cancer with MET gene alterations","url":"https://www.nice.org.uk/guidance/ta789"}],"tags":["gap-fill"],"related":["met-ex14"],"cancers":["nsclc","met-altered-nsclc","lung-cancer"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["met"],"drugs":["capmatinib"],"companies":["merck-kgaa"],"institutions":[],"pathways":[],"terms":[],"trials":["nct02864992"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Tepmetko","modality":"Small-molecule MET tyrosine kinase inhibitor","mechanism":"A highly selective, once-daily MET kinase inhibitor that blocks signalling from MET receptors kept active by exon 14 skipping mutations.","approvals":[{"region":"US","year":2021,"indication":"Metastatic NSCLC with MET exon 14 skipping alterations"},{"region":"EU","year":2022,"indication":"Advanced NSCLC with MET exon 14 skipping alterations after immunotherapy or platinum chemotherapy"},{"region":"JP","year":2020,"indication":"Unresectable advanced or recurrent NSCLC with MET exon 14 skipping"},{"region":"England (NICE)","year":2022,"indication":"Advanced non-small-cell lung cancer with MET exon 14 skipping alterations","note":"TA789, published 18 May 2022, subject to the commercial arrangement (VISION)."}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2021-02-03","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations."},{"date":"2024-02-15","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2021 converted to traditional approval 3.0 years after it was granted.","indication":"Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations."}]},"route":"/drugs/tepotinib/","neighbours":{"biomarker":[{"id":"met-amplification-readout","kind":"biomarker","name":"MET amplification (gene copy number)","route":"/biomarkers/met-amplification-readout/"},{"id":"met-ex14","kind":"biomarker","name":"MET exon 14 skipping mutation","route":"/biomarkers/met-ex14/"}],"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"met-altered-nsclc","kind":"cancer","name":"MET exon 14 and MET-amplified non-small-cell lung cancer","route":"/cancers/met-altered-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pulmonary-sarcomatoid-carcinoma","kind":"cancer","name":"Sarcomatoid carcinoma of the lung","route":"/cancers/pulmonary-sarcomatoid-carcinoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"met","kind":"target","name":"MET","route":"/targets/met/"}],"drug":[{"id":"capmatinib","kind":"drug","name":"Capmatinib","route":"/drugs/capmatinib/"}],"company":[{"id":"merck-kgaa","kind":"company","name":"Merck KGaA (EMD Serono)","route":"/companies/merck-kgaa/"}],"trial":[{"id":"nct06908993","kind":"trial","name":"Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated","route":"/trials/nct06908993/"},{"id":"nct02864992","kind":"trial","name":"VISION (tepotinib)","route":"/trials/nct02864992/"}],"paper":[{"id":"paper-wolf-geometry-mono-1-capmatinib-nejm-2020","kind":"paper","name":"Capmatinib in MET exon 14-mutated or MET-amplified non-small-cell lung cancer","route":"/key-papers/paper-wolf-geometry-mono-1-capmatinib-nejm-2020/"},{"id":"paper-awad-met-exon-14-mutations-lung-jco-2016","kind":"paper","name":"MET exon 14 mutations in non-small-cell lung cancer are associated with advanced age and stage-dependent MET genomic amplification and c-Met overexpression","route":"/key-papers/paper-awad-met-exon-14-mutations-lung-jco-2016/"},{"id":"paper-vision-tepotinib-paik-nejm-2020","kind":"paper","name":"VISION: tepotinib in non-small-cell lung cancer with MET exon 14 skipping mutations","route":"/key-papers/paper-vision-tepotinib-paik-nejm-2020/"}],"term":[{"id":"lung-uk-drug-access","kind":"term","name":"Lung cancer drugs in England: what NICE has recommended","route":"/terms/lung-uk-drug-access/"},{"id":"met-exon-14-skipping","kind":"term","name":"MET exon 14 skipping mutation","route":"/terms/met-exon-14-skipping/"}]}}