Drugs / Epcoritamab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Tepkinly | — | 2023-09-22 | europa.eu ↗ |
Trials 54 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT05692050 Background | — | lymphoma | AbbVie | No longer available | No outcome recorded |
Press releases naming this drug 24 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-23 | AbbVie | 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 ↗ |
| 2026-07-06 | AbbVie | 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 ↗ |
| 2026-06-29 | AbbVie | AbbVie Announces Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma abbvie.com ↗ |
| 2026-01-16 | AbbVie | 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 ↗ |
| 2025-11-18 | AbbVie | AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma abbvie.com ↗ |
| 2025-09-03 | AbbVie | 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 ↗ |
| 2024-12-09 | AbbVie | 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 ↗ |
| 2024-12-07 | AbbVie | 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 ↗ |
| 2024-08-19 | AbbVie | European Commission Grants Second Indication Approval for TEPKINLY® (epcoritamab) for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma abbvie.com ↗ |
| 2024-06-28 | AbbVie | AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma abbvie.com ↗ |
| 2024-06-26 | AbbVie | U.S. Food and Drug Administration Grants Second Approval for EPKINLY® (epcoritamab-bysp) to Treat Patients with Relapsed or Refractory Follicular Lymphoma abbvie.com ↗ |
| 2024-02-27 | AbbVie | 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 | 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 ↗ |
| 2023-11-27 | AbbVie | 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 ↗ |
| 2023-09-25 | AbbVie | AbbVie Announces European Commission Approval of TEPKINLY® (epcoritamab) for Adults with Relapsed or Refractory Diffuse Large B-cell Lymphoma abbvie.com ↗ |
| 2023-07-21 | AbbVie | AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) abbvie.com ↗ |
| 2023-06-27 | AbbVie | 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 | 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 ↗ |
| 2022-12-11 | AbbVie | AbbVie Presents Data at the 64th American Society of Hematology (ASH) Annual Meeting Evaluating Epcoritamab (DuoBody®-CD3xCD20) Across B-Cell Lymphomas abbvie.com ↗ |
| 2022-11-21 | AbbVie | 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 ↗ |
| 2022-10-28 | AbbVie | 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 ↗ |
| 2022-06-11 | AbbVie | 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 ↗ |
| 2022-04-13 | AbbVie | 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 ↗ |
| 2021-09-09 | AbbVie | 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 ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Epcoritamab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07197307 ↗54 |
| 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 ↗ |