U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Retrieved on:
torsdag, november 9, 2023
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The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 14, 2024.
Key Points:
- The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) 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.
- “This FDA acceptance brings us one step closer to offering these patients, for the first time, a personalized, T-cell based treatment option.
- 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.