Epkinly
Epkinly ingredients
| Active ingredient | Strength |
|---|---|
| Epcoritamab | 4 mg/.8mL, 48 mg/.8mL |
What Epkinly is used for
The FDA lists the approved uses on the official label (below). In the EU, epcoritamab is approved as Tepkinly for:
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.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Epkinly
- Generic name
- Epcoritamab-bysp
- Made by
- Genmab US, Inc.
- Forms
- Injection, Solution
- Given
- Subcutaneous
- Drug class
- Bispecific CD20-directed CD3 T Cell Engager
- FDA approval
- Biologic licence (BLA) BLA761324
- On the US market since
- 2023
Official information
- Epkinly prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Epcoritamab-bysp)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Epkinly?
Epkinly (Epcoritamab-bysp) is a cancer medicine made by Genmab US, Inc., approved by the US FDA.
What are the ingredients of Epkinly?
Epkinly contains Epcoritamab (4 mg/.8mL, 48 mg/.8mL).
Is Epkinly approved in Europe?
The same active substance is approved in the EU as Tepkinly.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA