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FDA Approves Breyanzi for Advanced Large B-Cell Lymphoma

On February 5, 2021, the FDA approved lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb), a new chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after ≥2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma. The FDA granted this application priority review, breakthrough therapy, and orphan drug designation. Lisocabtagene maraleucel is not indicated for patients with primary central nervous system lymphoma.

The approval of lisocabtagene maraleucel was based on data from the multicenter, clinical trial, TRANSCEND NHL 001, which included 269 patients with relapsed or refractory large B-cell lymphoma. The efficacy analysis, which included 256 patients, showed an objective response rate (ORR) of 73% and a complete response rate of 53% after 1 infusion.

According to the safety analysis, any grade cytokine release syndrome (CRS) occurred in 46% of patients, with 4% being grade ≥3. One patient had fatal CRS and 2 patients had ongoing CRS at the time of death. Neurologic toxicities of any grade occurred in 35% of patients, with grade ≥3 neurologic toxicities occurring in 12% of patients. Three patients had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at the time of death. The most common (≥20%) nonlaboratory adverse events (AEs) of any grade were fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections, decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema.

Lisocabtagene maraleucel will include a boxed warning that outlines the risks for CRS and neurologic toxicities associated with CAR T-cell therapy. The FDA also is requiring the manufacturer to conduct a postmarketing observational study of patients treated with lisocabtagene maraleucel to comply with its Risk Evaluation and Mitigation Strategy monitoring program.

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