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May 22, 2023May 19, 2023 – AbbVie has announced that the U.S. Food and Drug Administration 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. Epkinly 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.
Epkinly is approved under the FDA's Accelerated Approval program based on response rate and durability of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Epkinly is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.
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.