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Epcoritamab is an under-the-skin injection that pulls T cells onto lymphoma cells; it is approved for relapsed large B-cell and follicular lymphoma, and moving toward first line.
EPCORE NHL-1: ORR 63%, CR 39% in DLBCL after ≥2 lines; 3-year data show ~53% of complete responders in durable remission. Accelerated approval May 2023 (DLBCL) and 2024 (follicular lymphoma). Phase 3 EPCORE DLBCL-1 (R/R, vs investigator's choice, topline January 2026): PFS HR 0.74 but OS HR 0.96, not significant, so the US primary endpoint was missed. EPCORE DLBCL-2 (frontline, with R-CHOP) topline 2026 and EHA 2026 presentation; EPCORE FL-1 positive in follicular lymphoma. Genmab/AbbVie; 2025 label change allowed outpatient step-up dosing.
1.Subcutaneous injection; slow absorption blunts cytokine peaks
Source: www.epkinly.com. Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting. Subcutaneous, clinician-administered.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA954 · NHS England Cancer Drugs Fund list · SMC advice: epcoritamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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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.
Accelerated approval in DLBCL (EPCORE NHL-1) The confirmatory requirement was still open 3.3 years later, when the FDA's table was read.
Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source
Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
Confirmed: the accelerated approval of 2024 converted to traditional approval 1.4 years after it was granted. source
EPCORE DLBCL-1 topline: PFS met, OS (US primary endpoint) not met source
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Relapsed/refractory DLBCL or high-grade B-cell lymphoma after ≥2 lines (accelerated) |
| US | 2024 | Relapsed/refractory follicular lymphoma after ≥2 lines (accelerated; full 2025 with R2) |
| EU | 2023 | EU brand Tepkinly · Conditional marketing authorisation |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Cytokine release syndrome | 49.7% | 2.5% |
| ICANS | 6.4% | 0.6% |
| Neutropenia | - | 14.6% |
| Infections | - | 14.6% |
EPCORE NHL-1 DLBCL cohort. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (bispecific t-cell engagers) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
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Query for this drug: (TITLE:"Epcoritamab" OR ABSTRACT:"Epcoritamab" OR TITLE:"Epkinly" OR ABSTRACT:"Epkinly") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Epcoritamab, not a curated reading list.
Shares A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas, Head-to-head bispecific vs CAR-T in second-line LBCL, Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, Step-up dosing (T-cell engagers).
Shares A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas, Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, CD20 expression (CD20-positive).
Shares CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, POD24: progression of follicular lymphoma within two years, and why it changes the plan, Cytokine release syndrome and ICANS: grading and management.
Shares EPCORE DLBCL-1, EPCORE NHL-1, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, CD3.
Shares Head-to-head bispecific vs CAR-T in second-line LBCL, Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, POD24: progression of follicular lymphoma within two years, and why it changes the plan, Cytokine release syndrome and ICANS: grading and management.
Shares Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, CD20 expression (CD20-positive), Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, Cytokine release syndrome and ICANS: grading and management.
Shares Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, Cytokine release syndrome and ICANS: grading and management, What the NHS in England funds for lymphoma, appraisal by appraisal, ICANS (neurotoxicity).
Shares EPCORE NHL-1, CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, T-cell engagers (bispecific).