Drugs / Epcoritamab
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diffuse large B-cell lymphoma 1 milestone | |||||
| Filed | EU (EMA) | — | diffuse large B-cell lymphoma | 2022-10-28 | “In October 2022 , a Marketing Authorization Application was submitted for epcoritamab for the treatment of patients with R/R DLBCL” abbvie.com ↗ “today announced that the European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for epcoritamab” abbvie.com ↗ “In October 2022, a Marketing Authorization Application was submitted for epcoritamab for the treatment of patients with R/R DLBCL” abbvie.com ↗ |
| Filed follicular lymphoma, susceptibility to 2 milestones | |||||
| Filed | US (FDA) | EPKINLY | follicular lymphoma, susceptibility to | 2024-02-27 | “FDA has granted Priority Review of the supplemental Biologics License Application (sBLA) for epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody...” abbvie.com ↗ “the FDA granted Priority Review of the supplemental Biologics License Application (sBLA) for Epkinly (epcoritamab), for the treatment of adult relapsed or refractory (R/R)...” abbvie.com ↗ “Epcoritamab advancing to earlier lines of therapy with the submission of a sBLA to the FDA for epcoritamab plus R2 in patients with relapsed or refractory FL” genmab.com ↗ |
| Filed | EU (EMA) | TEPKINLY | follicular lymphoma, susceptibility to | 2023-11-27 | “Additionally, the European Medicines Agency (EMA) has validated a Type II application for epcoritamab in the same indication.” abbvie.com ↗ “Additionally, the EMA has validated a Type II application for epcoritamab (TEPKINLY ® ) for the same indication.” abbvie.com ↗ |
| Filed large B-cell lymphoma 1 milestone | |||||
| Filed | Japan (PMDA) | — | large B-cell lymphoma | — | “Additionally, in December 2022 , a Japan new drug application was submitted to the Ministry of Health, Labor and Welfare of Japan for epcoritamab for the treatment of patients...” abbvie.com ↗ “Additionally, in December 2022, a Japan new drug application was submitted to the Ministry of Health, Labor and Welfare of Japan for epcoritamab for the treatment of patients...” genmab.com ↗ “Regulatory submissions for subcutaneous (SC) epcoritamab were made in the U.S. and Japan by Genmab and in Europe by AbbVie.” genmab.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved · conditional | EU (EMA) | Tepkinly | — | 2023-09-22 | europa.eu ↗ |
Trials 58
News releases announcing trial results or a regulatory action · 43
| Date | Issuer | Release |
|---|---|---|
| 2026-10-05 | Vitae Pharmaceuticals, Inc. | Results AbbVie and Genmab Announce Epcoritamab in Combination with R-CHOP Demonstrates Significant Improvement in Progression-Free Survival versus R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma abbvie.com ↗
The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in DLBCL patients with an IPI score of 2 to 5. |
| 2026-10-05 | Genmab | Results Genmab and AbbVie Announce Epcoritamab in Combination with R-CHOP Demonstrates Statistically Significant Improvement in Progression-Free Survival in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma genmab.com ↗
The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in DLBCL patients with an IPI score of 2 to 5. |
| 2026-07-23 | AbbVie | Results Genmab and AbbVie Provide Clarification on Phase 3 EPCORE® DLBCL-1 Trial Evaluating Epcoritamab (DuoBody® CD3xCD20) in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) abbvie.com ↗
In the United States, where overall survival (OS) is the sole primary endpoint, the study did not demonstrate a statistically significant improvement in OS and therefore did not meet its primary endpoint. |
| 2026-07-06 | AbbVie | Regulatory AbbVie Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Commission (EC) granted marketing authorization for TEPKINLY® (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). |
| 2026-06-29 | AbbVie | Results AbbVie Announces Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma abbvie.com ↗
Topline results from Phase 3 EPCORE® DLBCL-4 trial evaluating epcoritamab in combination with lenalidomide demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma |
| 2026-06-29 | Genmab | Results Genmab Announces Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Demonstrating Statistically Significant Improvement in Progression-Free Survival genmab.com ↗
Based on topline results, the trial met its primary objective, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS). |
| 2026-06-08 | AbbVie | Results AbbVie Presents New Data Across Its Blood Cancer Portfolio at EHA 2026 abbvie.com ↗
The study showed a statistically significant improvement in PFS versus investigator's choice of chemoimmunotherapy (CIT) — either rituximab plus gemcitabine plus oxaliplatin or bendamustine plus rituximab (HR 0.74 [95% CI, 0.60–0.92]; P=0.0059; 24-month PFS: 30% vs 13%). |
| 2026-01-16 | AbbVie | Results AbbVie Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) abbvie.com ↗
The study demonstrated an improvement in progression-free survival (PFS) (HR: 0.74 [95% CI 0.60 to 0.92])*. |
| 2025-12-02 | AbbVie | Results AbbVie to Feature New Data at ASH 2025 Showcasing Continued Advances Across Novel Treatment Modalities in Multiple Blood Cancers abbvie.com ↗
In the E+R 2 group, CRS events were at a low grade, and all resolved eventually. |
| 2025-11-18 | AbbVie | Regulatory AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma abbvie.com ↗ |
| 2025-11-18 | Genmab | Regulatory Genmab Announces EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide Approved by the U.S. Food and Drug Administration for the Treatment of Relapsed or Refractory Follicular Lymphoma genmab.com ↗
Genmab A/S (Nasdaq: GMAB) announced today that EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) was approved by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). |
| 2025-11-03 | Genmab | Results Genmab to Showcase Latest Blood Cancer Treatment Advancements at 2025 American Society of Hematology (ASH) Annual Meeting genmab.com ↗
New data demonstrate potential of epcoritamab in first and second-line settings in follicular lymphoma (FL) and first-line in diffuse large B-cell lymphoma (DLBCL) |
| 2025-09-03 | AbbVie | Results AbbVie Announces Updated Results From Phase 2 EPCORE® NHL-6 Study Evaluating the Potential for Outpatient Monitoring of Epcoritamab in Patients With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) abbvie.com ↗
Results from the study demonstrated that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL. |
| 2025-08-07 | Genmab | Results Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) genmab.com ↗
Epcoritamab in combination with rituximab and lenalidomide (R2) demonstrated statistically significant improvement in Overall Response Rate (ORR; 95.7%, p < 0.0001) and Progression-Free Survival (HR 0.21, p-value <0.0001) versus R2 alone in patients with relapsed/refractory (R/R) Follicular Lymphoma (FL) |
| 2025-06-16 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents First Data from the Marginal Zone Lymphoma Cohort of the Transcend FL Trial Demonstrating Deep and Durable Responses with Breyanzi (lisocabtagene maraleucel) bms.com ↗
The data support liso-cel as an effective treatment for patients with third-line plus R/R FL, potentially offering improved efficacy over epcoritamab in this setting. |
| 2025-05-02 | Genmab | Results Genmab to Submit Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed/Refractory Follicular Lymphoma (FL) genmab.com ↗
Based on an interim analysis conducted by an Independent Data Monitoring Committee (IDMC) review, the study met one of its dual primary endpoints of ORR (Complete Response plus Partial Response, p-value < 0.0001). |
| 2024-12-09 | AbbVie | Results Two Data Analyses From Clinical Trials Show Epcoritamab (DuoBody® CD3xCD20) Induces Durable Complete Reponses As Monotherapy and Combination Treatment in Patients With Diffuse Large B-Cell Lymphoma abbvie.com ↗
Results from this arm of the study showed an overall response rate (ORR) of 100% and a complete response (CR) rate of 87%. |
| 2024-12-07 | AbbVie | Results Investigational Epcoritamab (DuoBody® CD3xCD20) Combination Therapy Shows High Response Rates in Clinical Trial of Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) abbvie.com ↗
Among 111 patients with a median follow-up of over two years, overall response rate (ORR) was 96%, and complete response (CR) rate was 87%. |
| 2024-08-19 | AbbVie | Regulatory European Commission Grants Second Indication Approval for TEPKINLY® (epcoritamab) for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY ® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy. |
| 2024-08-19 | Genmab | Regulatory TEPKINLY® (epcoritamab) Receives Second European Commission Approval for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma genmab.com ↗
TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland. |
| 2024-06-28 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma abbvie.com ↗ |
| 2024-06-28 | Genmab | Regulatory Epcoritamab (TEPKINLY®) Receives Positive CHMP Opinion for the Treatment of Adults with Relapsed/ Refractory Follicular Lymphoma genmab.com ↗
Genmab A/S (Nasdaq: GMAB) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab (TEPKINLY®), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. |
| 2024-06-27 | Genmab | Regulatory EPKINLY® (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL) genmab.com ↗ |
| 2024-06-26 | AbbVie | Regulatory U.S. Food and Drug Administration Grants Second Approval for EPKINLY® (epcoritamab-bysp) to Treat Patients with Relapsed or Refractory Follicular Lymphoma abbvie.com ↗
EPKINLY is now the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL) |
| 2024-02-27 | AbbVie | Regulatory U.S. Food and Drug Administration (FDA) Grants Priority Review of Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma (FL) abbvie.com ↗ |
| 2023-12-09 | AbbVie | Results New Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Shows Strong, Durable Treatment Response for Patients with Difficult-To-Treat Relapsed/Refractory (R/R) Follicular Lymphoma (FL) abbvie.com ↗
More than half of patients who responded to treatment in the study remained responsive to treatment at the time of data analysis (i.e., median duration of response was not reached). |
| 2023-11-27 | AbbVie | Regulatory AbbVie Announces U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) Updates for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory Follicular Lymphoma abbvie.com ↗
The FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp (EPKINLY ® ) for the treatment of adult patients with R/R FL after two or more therapies. |
| 2023-09-25 | AbbVie | Regulatory AbbVie Announces European Commission Approval of TEPKINLY® (epcoritamab) for Adults with Relapsed or Refractory Diffuse Large B-cell Lymphoma abbvie.com ↗ |
| 2023-09-25 | Genmab | Regulatory Genmab Announces European Commission Approval of TEPKINLY® (epcoritamab) for Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) genmab.com ↗
TEPKINLY® (epcoritamab) is the first and only subcutaneous bispecific antibody approved as a monotherapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy |
| 2023-07-21 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) abbvie.com ↗ |
| 2023-07-21 | Genmab | Regulatory Genmab Announces AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) genmab.com ↗ |
| 2023-06-28 | Genmab | Results Genmab and AbbVie Announce Positive Topline Results from Phase 1/2 EPCORE™ NHL-1 Trial Evaluating Epcoritamab (DuoBody® CD3xCD20) in Patients with Relapsed/Refractory Follicular Lymphoma (FL) genmab.com ↗
The topline results from this cohort showed an overall response rate (ORR) of 82 percent as confirmed by an independent review committee (IRC), which exceeded the protocol prespecified threshold for efficacy. |
| 2023-06-27 | AbbVie | Results AbbVie and Genmab Announce Positive Topline Results from Phase 1/2 EPCORE™ NHL-1 Trial Evaluating Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory Follicular Lymphoma (FL) abbvie.com ↗ |
| 2023-05-19 | AbbVie | Regulatory EPKINLY™ (epcoritamab-bysp) Approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY TM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies. |
| 2023-05-19 | Genmab | Regulatory EPKINLY™ (epcoritamab-bysp) Approved by U.S. Food and Drug Administration as the First and Only Bispecific Antibody to Treat Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) genmab.com ↗
EPKINLY was approved under accelerated approval based on response rate and durability of response. |
| 2022-12-11 | AbbVie | Results AbbVie Presents Data at the 64th American Society of Hematology (ASH) Annual Meeting Evaluating Epcoritamab (DuoBody®-CD3xCD20) Across B-Cell Lymphomas abbvie.com ↗
Four oral presentations presented at ASH highlight data evaluating investigational epcoritamab for the treatment of relapsed/refractory (R/R) follicular lymphoma, previously untreated follicular lymphoma, R/R diffuse large B-cell lymphoma and Richter's syndrome |
| 2022-11-21 | AbbVie | Regulatory U.S. FDA Accepts for Priority Review the Biologics License Application for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for epcoritamab (DuoBody ® -CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. |
| 2022-10-28 | AbbVie | Regulatory AbbVie Announces Submissions of Regulatory Applications for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Large B-Cell Lymphoma (LBCL) abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the European Medicines Agency (EMA) has validated a Marketing Authorization Application (MAA) for epcoritamab (DuoBody ® -CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. |
| 2022-06-11 | AbbVie | Results AbbVie Announces Late-Breaking Results from Phase 2 Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory Large B-cell Lymphoma (LBCL) at the European Hematology Association (EHA) Annual Congress abbvie.com ↗
In this study, epcoritamab demonstrated efficacy with durable responses in patients who had previously received at least two prior lines of anti-lymphoma therapy including chimeric antigen receptor (CAR) T-cell therapy. |
| 2022-04-13 | AbbVie | Results AbbVie and Genmab Announce Topline Results for Epcoritamab (DuoBody®-CD3xCD20) from Phase 1/2 Trial in Patients with Relapsed/Refractory Large B-cell Lymphoma (LBCL) abbvie.com ↗
AbbVie (NYSE: ABBV) and Genmab A/S (Nasdaq: GMAB) today announced topline results from the first cohort of the EPCORE™ NHL-1 phase 1/2 clinical trial evaluating epcoritamab (DuoBody ® -CD3xCD20), an investigational subcutaneous bispecific antibody. |
| 2022-04-13 | Genmab | Results Genmab and AbbVie Announce Topline Results for Epcoritamab (DuoBody®-CD3xCD20) From Phase 1/2 Trial in Patients with Relapsed/Refractory Large B-cell Lymphoma (LBCL) genmab.com ↗
The topline results from this cohort demonstrated an overall response rate (ORR) of 63.1 percent as confirmed by an independent review committee (IRC), which exceeded the protocol prespecified threshold for efficacy. |
| 2021-09-09 | AbbVie | Results Clinical Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL) Published in The Lancet abbvie.com ↗
No dose-limiting toxicities were observed during the dose escalation, and 48mg was identified as the RP2D. |
| 2020-11-05 | AbbVie | Results AbbVie to Highlight Blood Cancer Leadership and Advancing Oncology Pipeline at the ASH 62ND Annual Meeting abbvie.com ↗
Subcutaneous Epcoritamab Induces Complete Responses With an Encouraging Safety Profile Across Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Subtypes Including Patients With Prior CAR-T Therapy: Updated Dose Escalation Data |
All press releases naming this drug 46 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 62 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | epcoritamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07860775 ↗ |
| Known as | DuoBody-CD3xCD20 | “The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy” NCT07226752 ↗2“The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting” NCT05733650 ↗ “Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in combination with other agents” NCT04663347 ↗ |
| Known as | Epcor | “Epcoritamab (Epcor) is a bispecific antibody recognizing the T-cell antigen CD3 and the B-cell antigen CD20.” NCT06287398 ↗ |
| Known as | Epcoritamab-bysp | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650393 ↗ |
| Known as | EPKINLY | “Epcoritamab (EPKINLY™), either by itself or together with other therapies” NCT04663347 ↗1“epcoritamab, also known as EPKINLY™ and GEN3013” NCT07226752 ↗ |
| Known as | GEN3013 | “The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting” NCT05733650 ↗2“Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in combination with other agents” NCT04663347 ↗ “epcoritamab, also known as EPKINLY™ and GEN3013” NCT07226752 ↗ |
| Known as | Tepkinly | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650393 ↗ |
| Action | Deplete | “activates T cells, directing them to kill malignant CD20+ B cells.” PMID 36548927 ↗ Dec 2022 |
| Modality | Monoclonal antibody | “a novel bispecific antibody that targets CD3 and CD20” PMID 34508654 ↗ Sep 2021 |
| Route | Subcutaneous | “administered by subcutaneous injections” NCT03625037 ↗ |
| Target | MS4A1 | “B-lymphocyte antigen CD20 binding agent” CHEMBL4650393 ↗ |