The FDA granted accelerated approval on Thursday to Bristol Myers Squibb Co.’s BMY of Breyanzi (lisocabtagene maraleucel, liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The approval covers patients who have received at least two prior lines of therapy.
In June 2022, the FDA approved Breyanzi for adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma.
This expanded 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 offers a personalized treatment option that can be delivered as a one-time infusion.
Chronic lymphocytic leukemia or small lymphocytic lymphoma are among the most common types of B-cell lymphoma.
The Phase 1/2 open-label, single-arm TRANSCEND CLL 004 study was the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL. The CR rate associated with Breyanzi treatment was 20%.
Among patients who achieved a CR, the median duration of response was not reached at the time of data cutoff. Among all responders (ORR = 45%), the median duration of response was 35.3 months.
High rates of minimal residual disease (MRD) negative status were observed across patients treated with Breyanzi who achieved a CR, with an MRD-negativity rate of 100% in the blood and 92.3% in the bone marrow.
BMY Price Action: Bristol Myers Squibb shares are up 0.25% at $52.62 on the last check Friday.
Photo: Courtesy Bristol Myers Squibb
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