FDA approves Bristol Myers Squibb’s Breyanzi for new indication

The US Food and Drug Administration (FDA) has granted accelerated approval for a new indication of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy from US pharma major Bristol Myers Squibb (NYSE: BMY).

Breyanzi is now authorized for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.

Given the accelerated approval, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s), the company noted. 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.