FDA accepts supplemental BLA for Breyanzi in large B-cell lymphoma after failure of first-line therapy.
Bristol Myers Squibb announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, to expand its current indication to include earlier use of Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) after failure of first-line therapy.
The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 24, 2022.
The sBLA is based on results from the Phase III TRANSFORM trial, a global, randomized, multicenter study evaluating Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus autologous hematopoietic stem cell transplant. Results showed Breyanzi provided highly statistically significant and clinically meaningful improvements in event-free survival, complete responses and progression-free survival, and a positive trend in overall survival in patients with LBCL whose disease was primary refractory or relapsed within 12 months after first-line therapy compared to standard of care. Results were presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2021.
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