Epkinly Granted Accelerated FDA Approval for Lymphoma

MONDAY, May 22, 2023 (HealthDay News) — The U.S. Food and Drug Administration has granted accelerated approval to Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma.

The recommended regimen consists of Epkinly administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. Step-up dosing is recommended with cycle 1 (0.16 mg on day 1; 0.8 mg on day 8; and 48 mg on day 15 and day 22), followed by fixed dosing of 48 mg weekly dosing during cycles 2 through 3, every other week during cycle 4 through 9, and then every four weeks on day 1 of subsequent cycles.

Approval was based on trial data from 148 patients with relapsed or refractory DLBCL. The overall response rate, assessed by an independent review committee, was 61 percent, with 38 percent of patients achieving complete responses. During a median follow-up of 9.8 months among responders, the estimated median duration of response was 15.6 months.

The prescribing information has a boxed warning for serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome. Infections and cytopenias are included as warnings and precautions. The most common (≥20 percent) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea, while the most common grade 3 to 4 laboratory abnormalities (≥10 percent) included decreases in lymphocyte count, neutrophil count, white blood cell count, hemoglobin, and platelets.

Accelerated approval of Epkinly was granted to Genmab.