Recently, Bristol Myers Squibb reported the FDA’s acceptance of Breyanzi sBLA for CLL/SLL with Priority Review. The PDUFA goal date is set for March 14, 2024, which clearly shows how much impact Breyanzi will have on the population that has limited treatment options.
In a release, Anne Kerber, senior VP and head of Late Clinical Development, HOCT, said there is no standard of care for people living with relapsed or refractory CLL or SLL after treatment with BTKi- and BCL2i-based regimens.
She added, “This FDA acceptance brings us one step closer to offering these patients, for the first time, a personalized, T-cell-based treatment option. We’re proud to further our commitment to bring the potential of CAR T cell therapy to more patients, building on Breyanzi’s foundation as a differentiated treatment option that has shown clinical benefit in the broadest array of B-cell malignancies.”
The pivotal TRANSCEND CLL 004 study data, presented at ASCO 2023, were the basis for the application’s acceptance. This Phase 1/2 multicenter trial is the first to demonstrate the clinical benefits of CD19-directed CAR T cell therapy in relapsed or refractory CLL post-BTKi and BCL2i treatment.
Source: 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)
https://news.bms.com/news/corporate-financial/2023/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Application-for-Breyanzi-lisocabtagene-maraleucelfor-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL/default.aspx
