{"entity":{"id":"linvoseltamab","kind":"drug","name":"Linvoseltamab","aka":[],"tldr":"Linvoseltamab is Regeneron's BCMA bispecific, approved in July 2025 with the highest complete-response rate of the class in its pivotal study.","summary":"Linvoseltamab is a fully human IgG4 BCMAxCD3 bispecific antibody built on Regeneron's Veloci-Bi platform, given intravenously with step-up dosing and moved to every-4-week dosing in patients who respond. In LINKER-MM1, patients with at least 3 prior lines including an anti-CD38 antibody had ORR 70% and CR or better 45%, the highest complete response rate of the BCMA bispecific class in a pivotal study. The FDA granted accelerated approval on 2 July 2025 after at least 4 prior lines, and the EU approved it in 2025. LINKER-MM3, comparing it with elotuzumab-pomalidomide-dexamethasone, is the confirmatory phase 3. Its place alongside teclistamab and elranatamab, which reached the market earlier, depends on whether the deeper responses and less frequent dosing hold up. It is the third BCMA bispecific for myeloma, notable for how many patients reach complete remission.","status":"approved","asOf":"2026-09-07","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Linvoseltamab"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":["bcma","cd3"],"drugs":[],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":["pivotal-trial"],"trials":["linker-mm1","nct05730036","nct07393282","nct06140524","nct05955508","nct06669247","nct05828511","nct07455851"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Lynozyfic","modality":"Bispecific T-cell engager (BCMA×CD3)","mechanism":"Fully human IgG4 BCMA×CD3 bispecific (Veloci-Bi), IV with step-up.","approvals":[{"region":"US","year":2025,"indication":"Relapsed/refractory myeloma after ≥4 lines (accelerated)"},{"region":"EU","year":2025,"indication":"R/R myeloma ≥3 lines; 23 Apr 2025 (conditional)","note":"Conditional marketing authorisation"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2025-07-02","type":"accelerated-approval","region":"US","note":"Accelerated approval (LINKER-MM1) The confirmatory requirement was still open 1.2 years later, when the FDA's table was read.","source":"https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-gcpt-receives-fda-accelerated-approval","indication":"Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody."}]},"route":"/drugs/linvoseltamab/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"},{"id":"smouldering-myeloma","kind":"cancer","name":"Smouldering multiple myeloma","route":"/cancers/smouldering-myeloma/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"bcma","kind":"target","name":"BCMA","route":"/targets/bcma/"},{"id":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"}],"company":[{"id":"regeneron","kind":"company","name":"Regeneron","route":"/companies/regeneron/"}],"term":[{"id":"pivotal-trial","kind":"term","name":"Pivotal (registrational) trial","route":"/terms/pivotal-trial/"}],"trial":[{"id":"nct06140524","kind":"trial","name":"A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With H","route":"/trials/nct06140524/"},{"id":"nct05955508","kind":"trial","name":"A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Deve","route":"/trials/nct05955508/"},{"id":"nct06669247","kind":"trial","name":"A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Mult","route":"/trials/nct06669247/"},{"id":"nct07393282","kind":"trial","name":"A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)","route":"/trials/nct07393282/"},{"id":"nct05730036","kind":"trial","name":"A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Re","route":"/trials/nct05730036/"},{"id":"nct07455851","kind":"trial","name":"A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma","route":"/trials/nct07455851/"},{"id":"nct05828511","kind":"trial","name":"A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnose","route":"/trials/nct05828511/"},{"id":"linker-mm1","kind":"trial","name":"LINKER-MM1","route":"/trials/linker-mm1/"}],"pairing":[{"id":"bispecific-infection-prophylaxis","kind":"pairing","name":"Caution: T-cell redirectors and infections","route":"/pairings/bispecific-infection-prophylaxis/"}],"biomarker":[{"id":"bcma-expression","kind":"biomarker","name":"BCMA expression","route":"/biomarkers/bcma-expression/"}]}}