The US agency has accepted the company’s supplemental Biologics License Application (sBLA) for the drug to expand its existing indication
Bristol-Myers Squibb facility in Wirral, England. (Credit: Rept0n1x/Wikipedia)
Bristol Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) priority review for its CD19-directed CAR T cell therapy Breyanzi (lisocabtagene maraleucel).
The US agency has accepted the company’s supplemental Biologics License Application (sBLA) for the drug to expand its existing indication.
Breyanzi was previously approved in the US for the treatment of relapsed or refractory LBCL, after two or more lines of systemic therapy.
The current sBLA seeks to expand the drug’s existing indication to include large B-cell lymphoma (LBCL), after the failure of first-line therapy.
FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 24 June 2022.
Bristol Myers Squibb cell therapy development senior vice president Anne Kerber 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.
“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.”
BMS has filed the sBLA based on results from the Phase 3 TRANSFORM trial, which evaluated Breyanzi as a second-line treatment compared to the standard of care.
The standard of care includes salvage chemotherapy followed by high-dose chemotherapy plus autologous hematopoietic stem cell transplant.
In the Phase 3 study, Breyanzi offered statistically significant and clinically meaningful improvements in event-free survival, complete responses and progression-free survival
Also, the treatment showed a positive trend in overall survival in LBCL patients whose disease was primary refractory or relapsed within 12 months after first-line therapy.
In a separate development, BMS has unveiled positive long-term efficacy and safety results for Zeposia (ozanimod) from the interim analysis of True North open-label extension study in patients with active ulcerative colitis (UC).
In the study, patients achieved clinical remission, clinical response, endoscopic improvement and their corticosteroid-free remission were maintained through Week 142.