Bristol Myers announces FDA acceptance of sBLA for Breyanzi

Bristol Myers Squibb announced that the U.S. Food and Drug Administration has accepted the supplemental Biologics License Application for Breyanzi to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL) who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act goal date of March 14, 2024. Priority Review designation underscores the high unmet need and the significant advancement Breyanzi may offer this patient population for which there is no standard of care and limited treatment options. The application was based on results from the primary analysis of the pivotal TRANSCEND CLL 004 study, a Phase 1/2, open-label, single-arm multicenter study, which were presented in an oral presentation during the 2023 American Society of Clinical Oncology Annual Meeting in June 2023. TRANSCEND CLL 004 is the first pivotal multicenter study to show clinical benefit with a CD19-directed CAR T cell therapy in patients with relapsed or refractory CLL after progression following treatment with a BTKi and BCL2i.