Epcoritamab History and Updates

163 events · 2018 – present

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

5
FDA Approvals
0
Label Revisions
158
Trial Milestones
0
Pivotal Publications
Epcoritamab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications201820192020202120222023202420252026202720282029203020312032203320342035203620372038Trial: NCT07588698 2026-07-15 → 2028-07-31 (primary completion)Trial: NCT07528352 2026-05-31 → 2030-06-30 (primary completion)Trial: NCT07365306 2026-04-15 → 2029-10-15 (primary completion)Trial: NCT07451652 2026-03-17 → 2027-09-30 (primary completion)Trial: NCT06919939 2026-01-07 → 2031-01-07 (primary completion)Trial: NCT07218510 2026-01-07 → 2029-06-08 (primary completion)Trial: NCT07097363 2025-12-07 → 2030-05-31 (primary completion)Trial: NCT07197307 2025-10-15 → 2030-01-15 (primary completion)Trial: NCT06796998 2025-10-13 → 2028-10-15 (primary completion)Trial: NCT06931652 2025-09-22 → 2028-01-31 (primary completion)Trial: NCT07108998 2025-08-22 → 2027-07-01 (primary completion)Trial: NCT07082868 2025-08-13 → 2028-08-31 (primary completion)Trial: NCT07030699 2025-08-13 → 2026-03-31 (primary completion)Trial: NCT07126236 2025-08-04 → 2031-12-31 (primary completion)Trial: NCT06905509 2025-07-31 → 2028-07-01 (primary completion)Trial: NCT06723457 2025-07-25 → 2027-02-18 (primary completion)Trial: NCT06676033 2025-07-18 → 2027-07-01 (primary completion)Trial: NCT06672705 2025-06-16 → 2026-12-31 (primary completion)Trial: NCT06811272 2025-06-05 → 2026-10-01 (primary completion)Trial: NCT06536049 2025-04-02 → 2027-08-31 (primary completion)Trial: NCT06575686 2025-03-11 → 2028-07-16 (primary completion)Trial: NCT06563596 2025-01-21 → 2028-03-01 (primary completion)Trial: NCT06447376 2025-01-14 → 2028-09-01 (primary completion)Trial: NCT06510491 2024-12-06 → 2027-04-30 (primary completion)Trial: NCT06510361 2024-11-20 → 2026-05-01 (primary completion)Trial: NCT06458439 2024-09-24 → 2027-10-31 (primary completion)Trial: NCT06508658 2024-08-13 → 2028-03-31 (primary completion)Trial: NCT06414148 2024-05-14 → 2026-10-31 (primary completion)Trial: NCT05791409 2024-04-10 → 2029-03-31 (primary completion)Trial: NCT06191744 2024-02-05 → 2037-11-30 (primary completion)Trial: NCT06238648 2024-01-31 → 2029-12-31 (primary completion)Trial: NCT06112847 2024-01-24 → 2026-07-17 (primary completion)Trial: NCT06045247 2024-01-05 → 2028-07-31 (primary completion)Trial: NCT06287398 2023-12-11 → 2026-11-30 (primary completion)Trial: NCT05852717 2023-10-31 → 2027-11-24 (primary completion)Trial: NCT05848765 2023-09-04 → 2029-05-31 (primary completion)Trial: NCT05783609 2023-06-21 → 2028-02-29 (primary completion)Trial: NCT05660967 2023-03-06 → 2026-06-14 (primary completion)Trial: NCT05578976 2023-02-08 → 2027-06-30 (primary completion)Trial: NCT07226752 2022-10-08 → 2025-10-13 (primary completion)Trial: NCT05206357 2022-10-04 → 2028-11-30 (primary completion)Trial: NCT05409066 2022-09-20 → 2029-12-31 (primary completion)Trial: NCT05451810 2022-08-17 → 2027-03-31 (primary completion)Trial: NCT05283720 2022-06-14 → 2032-11-30 (primary completion)Trial: NCT05201248 2022-03-10 → 2025-04-30 (primary completion)Trial: NCT04628494 2021-01-13 → 2025-10-13 (primary completion)Trial: NCT04623541 2020-11-25 → 2027-12-31 (primary completion)Trial: NCT04663347 2020-11-03 → 2027-09-30 (primary completion)Trial: NCT04542824 2020-08-20 → 2027-09-30 (primary completion)Trial: NCT04358458 2020-03-13 → 2022-11-21 (primary completion)Trial: NCT03625037 2018-06-26 → 2029-01-31 (primary completion)FDA approval — 2023-05-19 FDA approved Epkinly (epcoritamab-bysp) (BLA 761324) Sponsor: GENMAB US, INC.. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2024-06-26 FDA approved supplemental application for Epkinly (epcoritamab-bysp) — Efficacy (BLA 761324 S-3) Sponsor: GENMAB US, INC.. Class: Efficacy.FDA approval (supplemental) — 2025-09-11 FDA approved supplemental application for Epkinly (epcoritamab-bysp) — Labeling (BLA 761324 S-8) Sponsor: GENMAB US, INC.. Class: Labeling.FDA approval (supplemental) — 2025-11-18 FDA approved supplemental application for Epkinly (epcoritamab-bysp) — Efficacy (BLA 761324 S-9) Sponsor: GENMAB US, INC.. Class: Efficacy.FDA approval (supplemental) — 2026-03-27 FDA approved supplemental application for Epkinly (epcoritamab-bysp) — Efficacy (BLA 761324 S-10) Sponsor: GENMAB US, INC.. Class: Efficacy.Results posted — 2024-08-13 Trial results posted: NCT04358458 First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomastoday (2026-06-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Epcoritamab since 2018, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (4)

2026

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma
Primary completion· ClinicalTrials.gov
MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma
Primary completion· ClinicalTrials.gov
Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL
Primary completion· ClinicalTrials.gov
Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
Primary completion· ClinicalTrials.gov
A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relaps
Primary completion· ClinicalTrials.gov
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphami
Primary completion· ClinicalTrials.gov
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NH
Primary completion· ClinicalTrials.gov
Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-
Primary completion· ClinicalTrials.gov
Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab
Primary completion· ClinicalTrials.gov
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infus
Primary completion· ClinicalTrials.gov
Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or
Primary completion· ClinicalTrials.gov
Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
Primary completion· ClinicalTrials.gov
Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patient
Primary completion· ClinicalTrials.gov
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed
Primary completion· ClinicalTrials.gov
Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lympho
Primary completion· ClinicalTrials.gov
Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of
Primary completion· ClinicalTrials.gov
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change i
Primary completion· ClinicalTrials.gov
Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
Primary completion· ClinicalTrials.gov
Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Primary completion· ClinicalTrials.gov
Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment o
Primary completion· ClinicalTrials.gov
Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B
Primary completion· ClinicalTrials.gov
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous
Primary completion· ClinicalTrials.gov
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change i

Past events

2026
Trial started· ClinicalTrials.gov
External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed/Refractory DLBCL
Trial started· ClinicalTrials.gov
Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of
Trial started· ClinicalTrials.gov
Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
Trial started· ClinicalTrials.gov
Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lympho
2025
Trial started· ClinicalTrials.gov
Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment o
Trial started· ClinicalTrials.gov
Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Primary completion· ClinicalTrials.gov
A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in C
Primary completion· ClinicalTrials.gov
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Trial started· ClinicalTrials.gov
Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab
Trial started· ClinicalTrials.gov
A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)
Trial started· ClinicalTrials.gov
A Study of Epcoritamab With Lenalidomide and Tafasitamab in People With Diffuse Large B Cell Lymphoma
Trial started· ClinicalTrials.gov
Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B
Trial started· ClinicalTrials.gov
Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or
Trial started· ClinicalTrials.gov
Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
Trial started· ClinicalTrials.gov
Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders
Primary completion· ClinicalTrials.gov
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard
Trial started· ClinicalTrials.gov
Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
Trial started· ClinicalTrials.gov
Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
2024
Trial started· ClinicalTrials.gov
Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy
Trial started· ClinicalTrials.gov
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infus
Results posted· ClinicalTrials.gov
First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
Trial started· ClinicalTrials.gov
MRD-Directed Consolidation With Epcor-only or Epcor-R2 Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma
Trial started· ClinicalTrials.gov
Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL
Trial started· ClinicalTrials.gov
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change i
Trial started· ClinicalTrials.gov
Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
Trial started· ClinicalTrials.gov
Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma
Trial started· ClinicalTrials.gov
Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patient
2023
Trial started· ClinicalTrials.gov
Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL
Trial started· ClinicalTrials.gov
Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-
Trial started· ClinicalTrials.gov
Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma
Trial started· ClinicalTrials.gov
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphami
2022
Trial started· ClinicalTrials.gov
A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in C
Trial started· ClinicalTrials.gov
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed
Trial started· ClinicalTrials.gov
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change i
Trial started· ClinicalTrials.gov
A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relaps
Trial started· ClinicalTrials.gov
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous
Trial started· ClinicalTrials.gov
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard
2021
Trial started· ClinicalTrials.gov
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
2020
Trial started· ClinicalTrials.gov
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Trial started· ClinicalTrials.gov
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NH
2018

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.