Bristol Myers announces FDA grants accelerated approval of Breyanzi

Bristol Myers announced the FDA has granted accelerated approval of Breyanzi, a CD19-directed chimeric antigen receptor, or CAR, T cell therapy, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia, or CLL, or small lymphocytic lymphoma, or SLL, who have received at least two prior lines of therapy, including a Bruton tyrosine kinase, or BTK, inhibitor and a B-cell lymphoma 2, or BCL-2, inhibitor. 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. 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. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome, Neurologic Toxicities, and Secondary Hematological Malignancies.