BMS bags first approval for CAR-T therapy in chronic lymphocytic leukaemia

2024-03-15

细胞疗法免疫疗法上市批准临床结果加速审批

Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) became the first CAR-T therapy approved for use in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) following a nod from the FDA. The CD19-directed therapy was first authorised in the US in 2022 for the treatment of certain adults with large B-cell lymphoma.

Bryan Campbell, head of commercial, cell therapy at Bristol Myers Squibb, noted that “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.” The latest accelerated approval is based on response rate and duration of response data from the Phase I/II TRANSCEND CLL 004 study.

Results released last year showed that Breyanzi was associated with a complete response (CR) rate of 20%, while the median duration of response was 35.3 months. Meanwhile, 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.

Breyanzi’s new indication is for the treatment of adults with relapsed or refractory CLL or small lymphocytic lymphoma SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor BCL-2 inhibitor.

More to come.

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