{"entity":{"id":"telisotuzumab-vedotin","kind":"drug","name":"Telisotuzumab vedotin","aka":[],"tldr":"Telisotuzumab vedotin (Emrelis) is the first c-MET-directed ADC, approved in 2025 for lung cancer with high c-MET protein.","summary":"Telisotuzumab vedotin (Emrelis) is an anti-c-MET antibody linked to the microtubule inhibitor MMAE through a cleavable mc-vc-PABC linker; it needs no MET mutation, only high c-MET protein on the tumour surface, which it uses as a delivery address. It received accelerated approval in May 2025 for previously treated non-squamous NSCLC with high c-MET overexpression on the strength of LUMINOSITY (objective response rate around 35 percent), and is given at 1.9 mg/kg every 2 weeks. It is the first c-MET-directed ADC to reach approval, after Breakthrough Therapy designation in 2022. Peripheral neuropathy, fatigue, decreased appetite, peripheral oedema and nausea are the main toxicities, and interstitial lung disease and ocular symptoms are monitored. The confirmatory TeliMET NSCLC-01 trial is ongoing. It treats lung cancers that overproduce c-MET protein by using that protein as a doorway.","status":"approved","asOf":"2026-09-04","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Telisotuzumab%20vedotin"}],"tags":[],"related":["met-overexpression"],"cancers":["nsclc","met-altered-nsclc"],"sections":[],"technologies":["adc"],"targets":["met"],"drugs":[],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":["mc-vc-pabc"],"trials":["luminosity","nct06568939"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Emrelis","modality":"ADC","payload":"MMAE","linker":"mc-vc-PABC","mechanism":"Anti-c-MET antibody with MMAE.","approvals":[{"region":"US","year":2025,"indication":"c-MET-high non-squamous NSCLC, previously treated (accelerated)"}],"mechanismSteps":["Antibody binds c-MET on the tumour cell surface","Receptor-ADC complex is internalised by endocytosis","Trafficked to the lysosome; linker is cleaved or antibody degraded","MMAE is released inside the cell","Microtubule assembly is blocked; mitosis arrests","Tumour cell dies by apoptosis","Membrane-permeable payload diffuses to kill neighbouring antigen-negative cells (bystander effect)"],"dosing":{"route":"IV infusion","schedule":"1.9 mg/kg every 2 weeks","monitoring":"Peripheral neuropathy, ocular symptoms, ILD","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Peripheral neuropathy"},{"event":"Fatigue"},{"event":"Decreased appetite"},{"event":"Peripheral oedema"},{"event":"Nausea"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2022-01","type":"designation","region":"US","note":"Breakthrough Therapy designation, c-MET overexpressing NSCLC","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-05-14","type":"accelerated-approval","region":"US","note":"Accelerated approval, previously treated c-MET-high non-squamous NSCLC (LUMINOSITY) The confirmatory requirement was still open 1.3 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy."}]},"route":"/drugs/telisotuzumab-vedotin/","neighbours":{"biomarker":[{"id":"met-overexpression","kind":"biomarker","name":"c-Met protein overexpression (IHC 3+ in >= 50% of tumour cells)","route":"/biomarkers/met-overexpression/"},{"id":"met-amplification-readout","kind":"biomarker","name":"MET amplification (gene copy number)","route":"/biomarkers/met-amplification-readout/"}],"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/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"met","kind":"target","name":"MET","route":"/targets/met/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"}],"term":[{"id":"mc-vc-pabc","kind":"term","name":"mc-Val-Cit-PABC","route":"/terms/mc-vc-pabc/"},{"id":"met-amplification","kind":"term","name":"MET amplification (bypass resistance)","route":"/terms/met-amplification/"},{"id":"met-exon-14-skipping","kind":"term","name":"MET exon 14 skipping mutation","route":"/terms/met-exon-14-skipping/"},{"id":"mmae","kind":"term","name":"MMAE","route":"/terms/mmae/"},{"id":"tubulin-inhibitor-payloads","kind":"term","name":"Tubulin inhibitor payloads","route":"/terms/tubulin-inhibitor-payloads/"}],"trial":[{"id":"nct06568939","kind":"trial","name":"A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult ","route":"/trials/nct06568939/"},{"id":"luminosity","kind":"trial","name":"LUMINOSITY","route":"/trials/luminosity/"},{"id":"lung-map","kind":"trial","name":"Lung-MAP (SWOG S1400 and S1900)","route":"/trials/lung-map/"},{"id":"telimet-nsclc-01","kind":"trial","name":"TeliMET NSCLC-01","route":"/trials/telimet-nsclc-01/"},{"id":"nct07323641","kind":"trial","name":"Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer","route":"/trials/nct07323641/"}],"roadmap":[{"id":"adc-generations","kind":"roadmap","name":"ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs","route":"/roadmaps/adc-generations/"}],"pathway":[{"id":"nsclc-signalling","kind":"pathway","name":"Non-small cell lung cancer (KEGG map)","route":"/pathways/nsclc-signalling/"},{"id":"rtk-activation","kind":"pathway","name":"Receptor tyrosine kinase activation","route":"/pathways/rtk-activation/"}]}}