Drug · Monoclonal Antibody
Epcoritamab
CI-DRUG-00000759Explore in graph →CHEMBL4650393 Approved
Regulatory
Approvals (8)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2026-03-27 (see label) | approved | Mar 27, 2026 | openfda |
| US FDA | — | Efficacy supplement 2025-11-18 (see label) | approved | Nov 18, 2025 | openfda |
| US FDA | — | Efficacy supplement 2024-06-26 (see label) | approved | Jun 26, 2024 | openfda |
| US FDA | — | 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. • As monotherapy for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy. | approved |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 9 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 53 | 30 | 6 | 57 | 8 | CA, EU, US | May 19, 2023 | Jun 26, 2018 |
| Non-Hodgkin Lymphoma | Approved | Phase 3 | 42 | 21 | 6 | 45 | 1 | US | May 19, 2023 | Jun 26, 2018 |
| Leukemia | Phase2 | Phase 2 | 5 | 2 | 0 | 6 | 0 | — | — | Mar 13, 2020 |
| Malignant Central Nervous System Neoplasm | Phase2 | Phase 2 | 2 | 2 | 0 | 2 | 0 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (59)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07126236 | Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma(REPIFIR) | recruiting | Phase 2 | 80 | Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaOTHER | 1 | Sep 29, 2026 | clinicaltrials |
| NCT06045247 | Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma |