The US Food and Drug Administration (FDA) has given accelerated approval to expand the use of Bristol Myers Squibb’s (BMS) cell therapy, Breyanzi (lisocabtagene maraleucel), for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy that improves the proliferation and durability of CAR T cells by including a 4-1BB costimulatory domain.
The drug was first authorised for use in June 2022 in the US to treat adult patients with large B-cell lymphoma who had stopped responding to treatment or whose disease had returned.
The latest approval is for treating adult patients with relapsed or refractory CLL or SLL.
Breyanzi has been authorised to be used in patients who received a minimum of two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
This indication was approved based on the response rate and duration of the response. Approval for this may continue contingent upon confirming and describing the clinical benefits in subsequent trial(s).
The first multicentre trial to assess a CAR T cell treatment in patients with relapsed or refractory CLL or SLL was the Phase 1/2 open-label, single-arm TRANSCEND CLL 004 study.
Breyanzi therapy was linked to a 20% complete response (CR) rate, which was the primary endpoint.
At the time of data cutoff, the median duration of response among patients who achieved a CR had not been attained. The median response duration of all respondents was 35.3 months in the clinical trial.
Patients treated with the CAR T cell therapy who obtained a CR exhibited high rates of minimum residual disease (MRD) negative status, with an MRD-negativity rate of 100% in the blood and 92.3% in the bone marrow.
Bristol Myers Squibb senior vice president and commercial, cell therapy head Bryan Campbell said: “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 personalised option, while further expanding access across the broadest array of B-cell malignancies, to address this critical unmet need.”
Breyanzi is also under priority review by the FDA for the indications of follicular lymphoma and mantle cell lymphoma. The regulator is expected to make a decision on these in late May 2024.
