PharmaRadar360

PharmaRadar360

OncologyDrug intelligence

Epkinly

Epcoritamab

CD3 x CD20 bispecific T-cell engaging antibody. Developed by Genmab. Clinical, regulatory, and source evidence are connected below.

Company
Genmab
Target / MOA
CD3 路 CD20
Aliases
Epkinly 路 Tepkinly
Signals
22
Clinical trials
20
Approvals
0
Evidence sources
22

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma

Phase 2 路 RECRUITING 路 University of Washington

clinical trialClinicalTrials.gov

Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)

Phase 2 路 NOT_YET_RECRUITING 路 National Heart, Lung, and Blood Institute (NHLBI)

clinical trialClinicalTrials.gov

Bispecific Antibody-Based Holding/Bridging Therapy Before CAR-T in Aggressive B-Cell Lymphomas

Phase 2 路 RECRUITING 路 National Research Center for Hematology, Russia

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Epkinly 路 BLA761324 路 label version 11, effective Jun 22, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 DLBCL and High-grade B-cell Lymphoma EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Follicular Lymphoma EPKINLY is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). EPKINLY is indicated as monotherapy for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy.

European Union (EMA)

Tepkinly 路 EMEA/H/C/005985 路 Authorised, authorised Sep 22, 2023 (Commission decision C(2023) 6532) 路 EPAR

Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

BLA761324 路 GENMAB US, INC. 路 first approved May 19, 2023

3 efficacy supplements approved

European Union

  • Tepkinly: Authorised since Sep 22, 2023

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

BLA761324 (Purple Book)

Orphan exclusivity until Jun 26, 2031

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

Epkinly label

WARNING: CYTOKINE RELEASE SYNDROME AND IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including serious or fatal reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosage schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.6) and Warnings and Precautions (5.1) ] . Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.6) and Warnings and Precautions (5.2) ] .

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 20 linked records.

Phase 2RECRUITINGNCT07097363

Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma

University of Washington 路 Updated Oct 21, 2026

Phase 2NOT YET RECRUITINGNCT07882173

Epcoritamab as Consolidative Therapy for Waldenstr(SqrRoot)(Delta)m Macroglobulinemia (WM) Treated With a Bruton Tyrosine Kinase Inhibitor (BTKi)

National Heart, Lung, and Blood Institute (NHLBI) 路 Updated Oct 21, 2026

Phase 2RECRUITINGNCT07883135

Bispecific Antibody-Based Holding/Bridging Therapy Before CAR-T in Aggressive B-Cell Lymphomas

National Research Center for Hematology, Russia 路 Updated Oct 20, 2026

Phase 2NOT YET RECRUITINGNCT07662928

Epcoritamab in Combination With Dose Adjusted EPOCH-R for High-risk Burkitt Lymphoma (BL), The BEDROCK Study

AIDS Malignancy Consortium 路 Updated Oct 16, 2026

Phase 2RECRUITINGNCT06796998

Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)

Izidore Lossos, MD 路 Updated Oct 15, 2026

Phase 2RECRUITINGNCT06919939

Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma

University of Miami 路 Updated Oct 15, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial 路 Latest Oct 21, 202620
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.