Bristol Myers Squibb gets FDA priority review for Breyanzi sBLA
Bristol Myers Squibb (BMS) has secured priority review from the US Food and Drug Administration (FDA) for its supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene maraleucel).
The sBLA is for expanding the current indication of the CD19-directed chimeric antigen receptor (CAR) T cell therapy to be used in the treatment of relapsed or refractory large B-cell lymphoma (LBCL) in adult patients in whom first-line therapy had failed.
The FDA has given a prescription drug user fee act (PDUFA) goal date of 24 June 24 to take a decision on the CAR T cell therapy of Bristol Myers Squibb.
Breyanzi has FDA approval for the treatment of relapsed or refractory LBCL after two or more lines of systemic therapy in adult patients.
Its sBLA is based on the findings of the TRANSFORM phase 3 trial. The late-stage clinical trial assessed Breyanzi as a second-line treatment in adult patients having relapsed or refractory LBCL in comparison to the standard of care consisting of salvage chemotherapy which was followed by high-dose chemotherapy and autologous hematopoietic stem cell transplant.
Results of the TRANSFORM phase 3 trial demonstrated that Breyanzi delivered improvements in event-free survival, complete responses and progression-free survival that were highly statistically significant and clinically meaningful, along with a positive trend in overall survival in patients having LBCL whose disease was primary refractory or relapsed within 12 months after being subjected to first-line therapy compared to standard of care.
Anne Kerber — Bristol Myers Squibb senior vice president of Cell Therapy Development said: “Breyanzi as a differentiated CD19-directed CAR T cell therapy 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.
“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.”