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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.
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.
1.One arm of Odronextamab binds CD20 on the cancer cell.
Sources: NICE search: odronextamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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CRLs for DLBCL and FL, confirmatory trial enrolment status
Conditional approval DLBCL and FL
Accelerated approval in follicular lymphoma
| Region | Year | Indication |
|---|---|---|
| EU | 2024 | R/R DLBCL and follicular lymphoma after ≥2 lines (conditional) |
| US | 2025 | R/R follicular lymphoma after ≥2 lines (accelerated) |
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An off-the-shelf alternative to CAR-T for repeatedly relapsed follicular lymphoma: no apheresis, no manufacturing wait, and a complete response rate in the same range, at the cost of continued treatment rather than a single infusion.
CD20 x CD3 bispecifics gave patients whose lymphoma has failed CAR-T, or who cannot access it, an effective off-the-shelf treatment that can be started within days. Epcoritamab and glofitamab are now standard third-line options and are moving into earlier lines and combinations. They do not yet replace CAR-T, whose remissions appear more durable.
Query for this drug: (TITLE:"Odronextamab" OR ABSTRACT:"Odronextamab" OR TITLE:"Lynozyfic" OR ABSTRACT:"Lynozyfic" OR TITLE:"EU: Ordspono" OR ABSTRACT:"EU: Ordspono") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Odronextamab, not a curated reading list.
Shares CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, POD24: progression of follicular lymphoma within two years, and why it changes the plan, Cytokine release syndrome and ICANS: grading and management.
Shares Fixed-duration, chemotherapy-free first-line treatment for the indolent lymphomas, CD3, CD20, T-cell engagers (bispecific).
Shares CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, POD24: progression of follicular lymphoma within two years, and why it changes the plan, Cytokine release syndrome and ICANS: grading and management.
Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, CD3, CD20, T-cell engagers (bispecific).
Shares CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, T-cell engagers (bispecific), 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.
Shares CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, T-cell engagers (bispecific), Diffuse large B-cell lymphoma.
Shares POD24: progression of follicular lymphoma within two years, and why it changes the plan, Fixed-duration, chemotherapy-free first-line treatment for the indolent lymphomas, CD3, CD20.
Shares CD3, CD20, T-cell engagers (bispecific), 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.