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These highlights do not include all the information needed to use EPKINLY safely and effectively. See full prescribing information for EPKINLY. EPKINLY® (epcoritamab-bysp) injection, for subcutaneous use Initial U.S. Approval: 2023
Medication labelWhy this: Advisory · dailymed-prescription
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). 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.
- generic_name
- epcoritamab-bysp
- product_names
- epcoritamab-bysp
- ndc
- 82705-010, 82705-010-01, 82705-002, 82705-002-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en