Bristol Myers’ Breyanzi CAR-T therapy approved by FDA in follicular lymphoma

The company states: “Bristol Myers announced the U.S. Food and Drug Administration has granted accelerated approval for Breyanzi, a CD19-directed chimeric antigen receptor T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma, or FL, who have received two or more prior lines of systemic therapy. 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). Breyanzi is also now included in the National Comprehensive Cancer Network for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL. In relapsed or refractory FL, Breyanzi is delivered as 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.”