FDA approves Breyanzi (lisocabtagene maraleucel; liso-cel) as the first and only CAR T cell therapy for adults with r/r chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

In R/R CLL or SLL, Breyanzi is delivered through a treatment process which culminates in a one-time infusion with a single dose containing 90 to 110 x 106 CAR-positive viable T cells.

"CAR T cell therapies represent a transformative treatment option for patients with certain types of blood cancers,” said Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb. “For years, attempts to bring other CAR T cell therapies to patients with relapsed or refractory CLL or SLL met challenges and found little success. With the approval of Breyanzi as the first CAR T for relapsed or refractory CLL or SLL, we are now able to offer these patients a personalized option, while further expanding access across the broadest array of B-cell malignancies, to address this critical unmet need.”

CLL and SLL are among the most common types of B-cell lymphoma. Treatments for people living with CLL or SLL primarily consist of targeted therapies including BTK- and BCL-2 inhibitors. However, patients often experience relapse or become refractory following early-line treatment with these therapies and there is no established standard of care for patients with double-class exposed CLL or SLL. After relapsing or becoming refractory to these therapies, patients have few options and poor outcomes, including lack of durable complete responses.