FDA grants priority review to Breyanzi for second-line treatment of large B-cell lymphoma
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The FDA granted priority review to lisocabtagene maraleucel as second-line treatment of adults with relapsed or refractory large B-cell lymphoma.
Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) — also known as liso-cel — is an autologous, gene-edited, CD19-directed chimeric antigen receptor T-cell therapy. The agent is approved in the U.S. for adults with relapsed or refractory diffuse large B-cell lymphoma who received two or more lines of systemic therapy.
Bristol Myers Squibb submitted a supplementary biologics license application to the FDA for the new indication and was given a Prescription Drug User Fee Act decision goal date of June 24.
The supplemental BLA was based on results from the randomized, phase 3 TRANSFORM study that compared liso-cel with standard-of-care treatment, which included salvage therapy followed by high-dose chemotherapy and allogeneic hematopoietic stem cell transplantation.
The study met its primary endpoint, as liso-cel significantly improved median EFS compared with standard therapy (10.1 months vs. 2.3 months; HR = 0.34; P < .0001). Liso-cel also significantly increased median PFS (14.8 months vs. 5.7 months; HR = 0.4; P = .0001), according to results presented at the ASH Annual Meeting & Exposition in December.
“Breyanzi... has already proven to be an important treatment option for patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy and now has the potential to be a new standard of care for patients after failure of first-line therapy, offering significantly improved outcomes beyond the current mainstay of care,” Anne Kerber, MD, senior vice president of cell therapy development at Bristol Myers Squibb, said in a company-issued press release. “This acceptance from the FDA brings us one step closer to delivering a practice-changing treatment for primary refractory or relapsed large B-cell lymphoma, making Breyanzi available to more patients in need, and underscores the advancements we’re making in cell therapy research to transform the lives of patients with difficult-to-treat blood cancers.”
Reference:
Kamdar M, et al. Abstract 91. Presented at: ASH Annual Meeting and Exposition; Dec. 11-14, 2021.
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