U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Supplemental Biologics License Application for Breyanzi (lisocabtagene maraleucel) as a Second-Line Therapy for Relapsed or Refractory Large B-cell Lymphoma
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
U.S. FDA has assigned a target action date of June 24, 2022
Excerpt from the Press Release:
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (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.
“Breyanzi as a differentiated CD19-directed CAR T cell therapyhas 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 nowhas 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,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers Squibb. “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, including lymphoma.”
The sBLA is based on results from the Phase 3 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.
TRANSFORM (NCT03575351) is a pivotal, global, randomized, multicenter Phase 3 trial evaluating Breyanzi compared to current standard of care regimens in adults with large B-cell lymphoma that is primary refractory or relapsed within 12 months after first-line therapy and who are intended for stem cell transplant.
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