Epkinly FDA Approval History
Last updated by Judith Stewart, BPharm on May 22, 2023.
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
Epkinly (epcoritamab-bysp) is a bispecific CD20-directed CD3 T-cell engager for use in the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
- 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. Continued approval for this indication 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). NHL is a cancer that develops in the lymphatic system and affects B-cells, a type of white blood cell. DLBCL patients are typically treated with chemoimmunotherapy-based regimens, but for patients with relapsed or refractory disease, several targeted therapies including T-cell mediated treatments are now available.
- 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.
- 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 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.
Development timeline for Epkinly
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
