{"entity":{"id":"odronextamab","kind":"drug","name":"Odronextamab","aka":[],"tldr":"Odronextamab is Regeneron's CD20 bispecific, approved in Europe for lymphoma and in the US for follicular lymphoma after earlier FDA rejections over confirmatory-trial enrolment.","summary":"Odronextamab is a fully human IgG4 CD20xCD3 bispecific antibody given intravenously with step-up dosing to limit cytokine release, redirecting T cells against CD20-positive lymphoma cells. In ELM-2 it produced ORR 52% and CR 31% in relapsed or refractory DLBCL after at least 2 lines, and ORR 80% with CR 73% in follicular lymphoma. The EU granted conditional approval for both indications in August 2024. In the US, the FDA issued complete response letters in March 2024 because confirmatory-trial enrolment was insufficient, then granted accelerated approval in follicular lymphoma in July 2025; the DLBCL indication remains unapproved there. Regeneron's OLYMPIA phase 3 programme is under way to confirm the results and move into earlier lines. It is one of several CD20 bispecifics, and its story shows that regulators now want confirmatory trials enrolling before granting accelerated approval.","status":"approved","asOf":"2026-09-07","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Odronextamab"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":["cd20","cd3"],"drugs":[],"companies":["regeneron"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06097364","nct06149286","nct06230224","nct06091865","nct06091254","nct03888105"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Lynozyfic (EU: Ordspono)","modality":"Bispecific T-cell engager (CD20×CD3)","mechanism":"Fully human IgG4 CD20×CD3 bispecific; IV step-up.","approvals":[{"region":"EU","year":2024,"indication":"R/R DLBCL and follicular lymphoma after ≥2 lines (conditional)"},{"region":"US","year":2025,"indication":"R/R follicular lymphoma after ≥2 lines (accelerated)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2024-03-25","type":"crl","region":"US","note":"CRLs for DLBCL and FL, confirmatory trial enrolment status"},{"date":"2024-08","type":"approval","region":"EU","note":"Conditional approval DLBCL and FL"},{"date":"2025-07-30","type":"approval","region":"US","note":"Accelerated approval in follicular lymphoma"}]},"route":"/drugs/odronextamab/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"},{"id":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"}],"company":[{"id":"regeneron","kind":"company","name":"Regeneron","route":"/companies/regeneron/"}],"trial":[{"id":"nct03888105","kind":"trial","name":"A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treat","route":"/trials/nct03888105/"},{"id":"nct06091865","kind":"trial","name":"A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Pa","route":"/trials/nct06091865/"},{"id":"nct06149286","kind":"trial","name":"A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participant","route":"/trials/nct06149286/"},{"id":"nct06230224","kind":"trial","name":"A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell ","route":"/trials/nct06230224/"},{"id":"nct06097364","kind":"trial","name":"A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemo","route":"/trials/nct06097364/"},{"id":"nct06091254","kind":"trial","name":"A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy ","route":"/trials/nct06091254/"}],"term":[{"id":"lymphoma-tx-bispecific-step-up","kind":"term","name":"CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one","route":"/terms/lymphoma-tx-bispecific-step-up/"},{"id":"lymphoma-tx-crs-icans","kind":"term","name":"Cytokine release syndrome and ICANS: grading and management","route":"/terms/lymphoma-tx-crs-icans/"},{"id":"lymphoma-tx-pod24","kind":"term","name":"POD24: progression of follicular lymphoma within two years, and why it changes the plan","route":"/terms/lymphoma-tx-pod24/"}],"paper":[{"id":"paper-epcore-nhl-1-epcoritamab-jco-2023","kind":"paper","name":"EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T","route":"/key-papers/paper-epcore-nhl-1-epcoritamab-jco-2023/"},{"id":"paper-elm-2-odronextamab-follicular-ann-oncol-2024","kind":"paper","name":"Safety and efficacy of odronextamab in patients with relapsed or refractory follicular lymphoma","route":"/key-papers/paper-elm-2-odronextamab-follicular-ann-oncol-2024/"}],"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"idea":[{"id":"lymphoma-ev-fixed-duration-chemotherapy-free-first-line","kind":"idea","name":"Fixed-duration, chemotherapy-free first-line treatment for the indolent lymphomas","route":"/ideas/lymphoma-ev-fixed-duration-chemotherapy-free-first-line/"}]}}