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drugsProductApproved2025🇪🇺🇬🇧

Odronextamab

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.

ELM-2: ORR 52%, CR 31% in R/R DLBCL after ≥2 lines; ORR 80%, CR 73% in follicular lymphoma. EU approval August 2024 (both); US complete response letters March 2024 over confirmatory-trial enrolment, then US accelerated approval in follicular lymphoma July 2025. OLYMPIA phase 3 programme ongoing.

Schematic of the modality · Bispecific T-cell engager (CD20×CD3) · not a molecule; see the T-cell engagers (bispecific) page
How it works, step by step · animated schematic, not to scale
T-cell engagers (bispecific) →
Modality
Bispecific T-cell engager (CD20×CD3)
Mechanism
Fully human IgG4 CD20×CD3 bispecific; IV step-up.
Brand / code
Lynozyfic (EU: Ordspono)
What the NHS offers (UK)
All products and how the system works →
Not yet researchedSearch NICE
Notes
MHRA-licensed 2025 (Ordspono); NICE appraisal in progress.

Sources: NICE search: odronextamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Where it is approved
US2025EU2024UK2025JPCNAUcompare regions →

Compare all products across the US, EU, UK, Japan, China and Australia →

Regulatory

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  1. 25 Mar 2024Complete response letterUS

    CRLs for DLBCL and FL, confirmatory trial enrolment status

  2. Aug 2024ApprovalEU

    Conditional approval DLBCL and FL

  3. 30 Jul 2025ApprovalUS

    Accelerated approval in follicular lymphoma

Approvals

RegionYearIndication
EU2024R/R DLBCL and follicular lymphoma after ≥2 lines (conditional)
US2025R/R follicular lymphoma after ≥2 lines (accelerated)

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
10 studies7 recruiting5 Phase 26 Phase 3
Search “Odronextamab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Odronextamab
intervention: Odronextamab
Open on ClinicalTrials.gov →

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Key papers

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translationalJournal of Clinical Oncology 2023changed practice
EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T

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.

Latest papers

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Literature trend12 papers in the last 12 months-54% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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Pages like this

not linked directly; found by shared links

cancers

2
Diffuse large B-cell lymphomaFollicular lymphoma

technologies

1
T-cell engagers (bispecific)

targets

2
CD20CD3

companies

1
Regeneron

key papers

1
EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T