The U.S. FDA approves Bristol Myers Squibb's Breyanzi ® as the first and only CAR-T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

In TRANSCEND CLL 004, the first multicenter pivotal trial to evaluate CAR-T cell therapy in patients with relapsed or refractory CLL or CLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with a median duration of CR not reached, as well as an established safety profile.

' 'CAR-T cell therapies represent a transformative treatment option for patients with certain types of blood cancers,' said Bryan Campbell, senior vice president, commercial lead, cell therapy, Bristol Myers Squibb.

' For years, attempts to bring other CAR-T cell therapies to patients with relapsed or refractory CLL or SLL have met with difficulty and little success. With the approval of Breyanzi as the first CAR T for relapsed or refractory CLL or CLL, we are now able to offer these patients a personalized option, while expanding access to the broadest range of B-cell malignancies, to address this critical unmet need.

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