Epkinly FDA Approval History
Last updated by Judith Stewart, BPharm on July 8, 2024.
FDA Approved: Yes (First approved May 19, 2023)
Brand name: Epkinly
Generic name: epcoritamab-bysp
Dosage form: Injection
Company: AbbVie Inc.
Treatment for: Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Epkinly (epcoritamab-bysp) is a bispecific CD20-directed CD3 T-cell engager for use in the treatment of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma.
- 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.
- adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
These indications are approved under accelerated approval based on response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - DLBCL is an aggressive, fast-growing cancer, and is the most common type of non-Hodgkin's lymphoma (NHL). FL is typically an indolent (or slow-growing) form of NHL. NHL is a cancer that develops in the lymphatic system and affects B-cells, a type of white blood cell.
- Epkinly is a bispecific antibody developed using proprietary DuoBody® technology designed to direct cytotoxic T-cells selectively to elicit an immune response towards target cell types. It works by simultaneously binding to CD3 on T-cells and CD20 on B-cells and induces T-cell mediated killing of CD20+ cells. CD20 is expressed on B-cells and is a clinically validated therapeutic target in many B-cell malignancies, including DLBCL and FL.
- Epkinly is administered by subcutaneous injection. The treatment schedule is divided into cycles of 28 days. Epkinly is usually given once every week during Cycles 1 to 3, once every 2 weeks during Cycles 4 to 9, and once every 4 weeks starting with Cycle 10.
- The Epkinly product label carries a Boxed Warning for cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Warnings and precautions include serious or fatal infections, serious or severe cytopenias, and fetal harm.
- - Common adverse reactions in DLBCL patients include cytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. Common laboratory abnormalities include decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.
- Common adverse reactions in FL patients include injection site reactions, cytokine release syndrome, COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache. Common laboratory abnormalities include decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and decreased hemoglobin.
Development timeline for Epkinly
Further information
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