$BMY announces @US_FDA has accepted its application for Priority Review for a treatment option for relapsed or refractory chronic lymphocytic leukemia (#CLL) or small lymphocytic lymphoma (#SLL). Read more: [LINK]

“Currently, there is no standard of care for people living with relapsed or refractory CLL or SLL after treatment with BTKi- and BCL2i-based regimens, leaving a critical unmet need for a treatment option that provides deep and lasting responses,” said Anne Kerber, senior vice president and head, Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb. “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 application was based on results from the primary analysis of the pivotal TRANSCEND CLL 004 study, a Phase 1/2, open-label, single-arm multicenter study, which were presented in an oral presentation during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2023. 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.