This story has been updated with the correct date of Breyanzi's approval as a third-line therapy in large B-cell lymphoma.
NEW YORK – Bristol Myers Squibb on Thursday said the US Food and Drug Administration has approved the CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) as a treatment for relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.
Patients who have received at least two prior lines of therapy including a BTK inhibitor and a BCL-2 inhibitor are eligible for treatment with Breyanzi. The product was approved under the accelerated approval pathway and confirmatory trials may be required for continued approval in this indication.
Breyanzi is the first CAR T-cell therapy approved in these indications. The agency's decision was based on data from the pivotal Phase I/II TRANSCEND CLL 004 trial in which 20 percent of patients treated with Breyanzi had a complete response and the median duration of complete response was not reached. Among all responders, the median duration of response was 35.5 months, and the rate of minimal residual disease negativity was 100 percent in the blood and 92.3 percent in the bone marrow.
The rate of cytokine release syndrome was 83 percent. However, most cases were low grade, with only 9 percent experiencing grade 3 cytokine release syndrome and no grade 4 or 5 cases reported.
"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," Bryan Campbell, BMS senior VP of cell therapy, said in a statement. "With the approval of Breyanzi … we are now able to offer these patients a personalized option, while further expanding access across the broadest array of B-cell malignancies to address unmet need."
Breyanzi was approved in 2021 in the US as a third-line therapy for large B-cell lymphoma. In February, Adam Lenkowsky, BMS chief commercialization officer, said that approval in CLL and SLL would "double the addressable patient population for Breyanzi."