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EPKINLY (EPCORITAMAB-BYSP)
EPKINLY (generic name: EPCORITAMAB-BYSP) is a drug developed by GENMAB US, INC.. It is currently FDA-approved for Relapsed or refractory diffuse large B-cell lymphoma.
At a glance
| Generic name | EPCORITAMAB-BYSP |
|---|---|
| Sponsor | GENMAB US, INC. |
| Target | B-lymphocyte antigen CD20, T-cell surface glycoprotein CD3 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Relapsed or refractory diffuse large B-cell lymphoma
Common side effects
- Cytokine Release Syndrome (CRS)
- Fatigue
- Musculoskeletal pain
- Injection site reactions
- Pyrexia/Fever
- Abdominal pain
- Nausea
- Diarrhea
- Rash
- COVID-19
- Upper respiratory tract infections
- Constipation
Serious adverse events
- Serious adverse reactions (overall)
- COVID-19 (fatal)
- Hepatotoxicity (fatal)
- ICANS (fatal)
- Myocardial infarction (fatal)
- Pulmonary embolism (fatal)
- Infections including sepsis
- Pleural effusion
- Febrile neutropenia
- ICANS
Key clinical trials
- A Phase 2 Study of Epcoritamab and Lenalidomide (E-Len) in Patients With Previously Untreated Follicular Lymphoma (FL) (Phase 2)
- A Phase II Study of Combination Epcoritamab-Lenalidomide in Patients With Refractory/Relapsed Immunodeficiency-Related Large B-Cell Lymphoma (Phase 2)
- A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicu (Phase 3)
- A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) (Phase 3)
- Phase 2 Study of Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma (Phase 2)
- A Phase II Clinical Study on Precision Treatment of Rare Tumours in China Guided by Patient-Derived Tumor Organoids (PDO) and Next-Generation Sequencing (NGS) (Phase 2)
- A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (Phase 3)
- A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B (Phase 3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- EPKINLY CI brief — competitive landscape report
- EPKINLY updates RSS · CI watch RSS
- GENMAB US, INC. portfolio CI
Frequently asked questions about EPKINLY
What is EPKINLY?
EPKINLY (EPCORITAMAB-BYSP) is a pharmaceutical drug developed by GENMAB US, INC., indicated for Relapsed or refractory diffuse large B-cell lymphoma.
What is EPKINLY used for?
EPKINLY is indicated for Relapsed or refractory diffuse large B-cell lymphoma.
Who makes EPKINLY?
EPKINLY is developed and marketed by GENMAB US, INC. (see full GENMAB US, INC. pipeline at /company/genmab-us-inc).
What is the generic name of EPKINLY?
EPCORITAMAB-BYSP is the generic (nonproprietary) name of EPKINLY.
What development phase is EPKINLY in?
EPKINLY is FDA-approved (marketed).
What are the side effects of EPKINLY?
Common side effects of EPKINLY include Cytokine Release Syndrome (CRS), Fatigue, Musculoskeletal pain, Injection site reactions, Pyrexia/Fever, Abdominal pain. Serious adverse events: Serious adverse reactions (overall), COVID-19 (fatal), Hepatotoxicity (fatal), ICANS (fatal).
What does EPKINLY target?
EPKINLY targets B-lymphocyte antigen CD20, T-cell surface glycoprotein CD3.
Related
- Target: All drugs targeting B-lymphocyte antigen CD20, T-cell surface glycoprotein CD3
- Manufacturer: GENMAB US, INC. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory diffuse large B-cell lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing