Odronextamab History and Updates

49 events · 2014 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
49
Trial Milestones
0
Pivotal Publications
Odronextamab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20152016201720182019202020212022202320242025202620272028202920302031Trial: NCT06975787 2025-12-22 → 2029-09-09 (primary completion)Trial: NCT07128641 2025-09-08 → 2027-01-02 (primary completion)Trial: NCT06784726 2025-09-04 → 2028-04-10 (primary completion)Trial: NCT06735664 2025-08-14 → 2027-12-13 (primary completion)Trial: NCT06854159 2025-08-07 → 2029-02-01 (primary completion)Trial: NCT05991388 2024-05-02 → 2031-05-01 (primary completion)Trial: NCT06230224 2024-02-15 → 2028-05-29 (primary completion)Trial: NCT06149286 2023-12-28 → 2029-01-23 (primary completion)Trial: NCT06091865 2023-12-13 → 2028-03-30 (primary completion)Trial: NCT06091254 2023-12-12 → 2028-02-07 (primary completion)Trial: NCT06097364 2023-11-14 → 2029-07-29 (primary completion)Trial: NCT05685173 2023-04-20 → 2029-02-16 (primary completion)Trial: NCT03888105 2019-11-13 → 2026-07-06 (primary completion)Trial: NCT02651662 2016-01-11 → 2026-05-31 (primary completion)Trial: NCT02290951 2015-01-09 → 2025-08-21 (primary completion)today (2026-06-09)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-09Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Odronextamab since 2014, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT03888105
A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previo
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06230224
A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressi
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06735664
Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06091254
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Che
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06091865
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, i
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06230224
A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressi
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06149286
A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult P
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06854159
Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Th
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05685173
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06097364
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined

Past events

2026
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT02651662
A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT02651662
A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
2025
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT02290951
Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06735664
Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06854159
Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Th
2024
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06230224
A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressi
2023
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06149286
A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult P
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06091865
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, i
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06091254
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Che
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06097364
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05685173
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
2022
2019
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT03888105
A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previo
2016
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT02651662
A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
2015
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT02290951
Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
2014

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.