The FDA approved Epkinly (epcoritamab-bysp) injection, a treatment for 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. Epkinkly is injected subcutaneously (under the skin) in 28-day cycles until disease progression or unacceptable toxicity.
Diffuse large B-cell lymphomas are the most common type of non-Hodgkin lymphoma cancer (in which cancer cells form in the lymph system) and are marked by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other tissues and organs. Signs and symptoms may include swollen lymph nodes, fever, extreme night sweats, fatigue, and weight loss. High-grade B-cell lymphoma is an aggressive form of B-cell lymphoma.
Epkinkly has a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome (ICANS). Warnings and precautions include infections and cytopenias. Among 157 patients with relapsed or refractory large B-cell lymphoma who received Epkinly at the recommended dose, CRS occurred in 51% of patients, ICANS in 6%, and serious infections in 15%. Epkinly should only be administered by a qualified health care professional with appropriate medical support to manage severe reactions such as CRS and ICANS. Because of the risk of CRS and ICANS, patients should be hospitalized for 24 hours after the Cycle 1 Day 15 dosage of 48 mg.
The most common adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, fever, abdominal pain, nausea, and diarrhea. The most common grade 3 to 4 laboratory abnormalities were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets. See the full prescribing information for additional information on risks associated with Epkinly.
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