Drugs / Odronextamab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed follicular lymphoma, susceptibility to 3 milestones | |||||
| Rejected (CRL) | US (FDA) | — | follicular lymphoma, susceptibility to | 2025-07-30 | “the FDA issued a Complete Response Letter (CRL) for the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in relapsed/refractory follicular lymphoma” regeneron.com ↗ “On July 30, 2025, the FDA issued a Complete Response Letter (CRL) for the BLA for odronextamab” regeneron.com ↗ |
| Filed | EU (EMA) | — | follicular lymphoma, susceptibility to | 2023-08-17 | “today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab” regeneron.com ↗ “A regulatory application for odronextamab has also been submitted in the European Union (EU).” regeneron.com ↗ |
| Filed | US (FDA) | — | follicular lymphoma, susceptibility to | — | “FDA has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma” regeneron.com ↗ “In January 2025, the Company resubmitted to the FDA the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in R/R follicular lymphoma.” regeneron.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Ordspono | — | 2024-08-22 | europa.eu ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06975787 | Dec 2025 → Sep 2029 expected | lupus nephritis | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT06735664 | Aug 2025 → Dec 2027 expected | Richter transformation | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT05685173 | Apr 2023 → Feb 2029 expected | aggressive B-cell non-Hodgkin lymphoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT02651662 | Jan 2016 → Apr 2026 | aggressive B-cell non-Hodgkin lymphoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02290951 | Jan 2015 → Aug 2025 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07128641 | Sep 2025 → Jan 2027 expected | follicular lymphoma | Gottfried von Keudell, MD PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT06784726 | Sep 2025 → Apr 2028 expected | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT06854159 | Aug 2025 → Oct 2028 expected | diffuse large B-cell lymphoma | University of California, Davis | Recruiting | No outcome recorded |
| Phase 2 | NCT03888105 | Nov 2019 → Jul 2026 overdue | B-cell non-Hodgkin lymphoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05991388 | May 2024 → May 2031 expected | B-cell non-Hodgkin lymphoma | University of Birmingham | Recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06230224 | Feb 2024 → May 2028 expected | aggressive B-cell non-Hodgkin lymphoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06149286 | Dec 2023 → Apr 2031 expected | marginal zone lymphoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06091865 | Dec 2023 → Mar 2028 expected | diffuse large B-cell lymphoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06091254 | Dec 2023 → Feb 2028 expected | follicular lymphoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06097364 | Nov 2023 → Jul 2029 expected | follicular lymphoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT05619367 Background | — | high grade B-cell lymphoma | Regeneron Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-02-26 | Regeneron Pharmaceuticals | Regulatory Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. |
| 2024-12-09 | Regeneron Pharmaceuticals | Results Odronextamab ASH Presentations Underscore Impressive Potential in Earlier Lines of Treatment and Additional Types of Lymphoma regeneron.com ↗
In Part 1 (N=13), odronextamab led to complete responses (CR) in all 12 patients evaluable for efficacy at week 12. |
| 2024-08-26 | Regeneron Pharmaceuticals | Regulatory Ordspono™ (odronextamab) Approved in the European Union for the Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma regeneron.com ↗
This marks the first regulatory approval of Ordspono in the world for these patients. |
| 2024-06-28 | Regeneron Pharmaceuticals | Regulatory Odronextamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma regeneron.com ↗ |
| 2024-03-25 | Regeneron Pharmaceuticals | Regulatory Regeneron Provides Update on Biologics License Application for Odronextamab regeneron.com ↗
The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing. |
| 2023-12-10 | Regeneron Pharmaceuticals | Results Updated Odronextamab Data from Relapsed/Refractory Diffuse Large B-cell Lymphoma Pivotal Trial Showed Deep and Durable Responses and the Potential of ctDNA To Predict Long-term Outcomes regeneron.com ↗
Phase 2 primary analysis results presented in ASH oral session demonstrated a 52% objective response rate (ORR), with 31% achieving a complete response (CR) |
| 2023-12-10 | Regeneron Pharmaceuticals | Results Latest Odronextamab Data in Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses and Overall Maintenance of Patient-Reported Outcomes regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data for odronextamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL) from a pivotal Phase 2 trial (ELM-2). |
| 2023-11-03 | Regeneron Pharmaceuticals | Results Regeneron to Highlight Scientific Advancements Across Diversified Pipeline in Difficult-to-Treat Blood Cancers and Disorders at ASH regeneron.com ↗
Odronextamab Demonstrates Durable Complete Responses in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing After CAR-T Therapy: Outcomes from the ELM-1 Study |
| 2023-09-29 | Regeneron Pharmaceuticals | Regulatory Odronextamab BLA for Treatment of Relapsed/Refractory Follicular Lymphoma (FL) and Diffuse Large B-cell Lymphoma (DLBCL) Accepted for FDA Priority Review regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. |
| 2023-08-17 | Regeneron Pharmaceuticals | Regulatory Odronextamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for odronextamab to treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies. |
| 2022-12-12 | Regeneron Pharmaceuticals | Results Odronextamab (CD20xCD3) Demonstrates High and Durable Complete Response Rate among Patients with Relapsed/Refractory Follicular Lymphoma in Pivotal Phase 2 Trial regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive first data from a cohort of a pivotal Phase 2 trial evaluating investigational odronextamab in patients with heavily pre-treated, relapsed/refractory (R/R) follicular lymphoma (FL) grades 1 to 3a. |
| 2022-12-11 | Regeneron Pharmaceuticals | Results Pivotal Odronextamab (CD20xCD3) Phase 2 Data in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma Debut at ASH regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive new and updated data from a Phase 1 and pivotal Phase 2 trial (ELM-1 and ELM-2) evaluating investigational odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). |
| 2019-06-14 | Regeneron Pharmaceuticals | Results Regeneron CD20xCD3 Bispecific REGN1979 Shows Positive Results in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, including in CAR-T Failures regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive early-stage data for REGN1979 in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). |
| 2018-12-01 | Regeneron Pharmaceuticals | Results Regeneron Presents Positive Data at ASH for REGN1979 CD20xCD3 Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma regeneron.com ↗
REGN1979 also showed encouraging dose-dependent clinical activity in heavily pre-treated patients with R/R DLBCL. |
All press releases naming this drug 17 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | odronextamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02651662 ↗ |
| Known as | REGN1979 | “A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Versus Standard of Care...” NCT06230224 ↗ |
| Action | Deplete | “triggering T-cell-mediated cytotoxicity independent of T-cell-receptor recognition” PMID 34997701 ↗ Jan 2022 |
| Modality | Monoclonal antibody | “Odronextamab is a fully-human IgG4-based CD20xCD3 bispecific antibody” PMID 34997701 ↗ Jan 2022 |
| Route | Intravenous | “Administered by intravenous (IV) infusion” NCT02290951 ↗ |
| Target | MS4A1 | “B-lymphocyte antigen CD20 binding agent” CHEMBL4298084 ↗ |