FDA Approves Breyanzi® as First-of-Its-Kind Cell Therapy for Relapsed/Refractory CLL/SLL
Bristol Myers Squibb has recently announced the U.S. Food and Drug Administration (FDA) accelerated approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy.
This approval targets adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
Approval is contingent upon response rate and duration of response, with further confirmation of clinical benefit needed for continued approval.
Cell Therapy, Bryan Campbell, this approval signifies a significant advance in treatment options for certain blood cancers. Prior attempts to introduce CAR T cell therapies for relapsed or refractory CLL or SLL faced challenges.
Breyanzi's approval now offers a personalized treatment option for patients across a range of B-cell malignancies.
CLL and SLL are among the most common types of B-cell lymphoma, typically treated with targeted therapies like BTK and BCL-2 inhibitors.
The approval of Breyanzi is based on promising results from the Phase 1/2 TRANSCEND CLL 004 study, showing a complete response rate of 20% and a median duration of response not yet reached among those achieving a complete response.
Patients responding to Breyanzi treatment displayed a median duration of response of 35.3 months, with high rates of minimal residual disease negativity observed.
This approval, suggesting a potential shift from continuous therapy to a one-time personalized T-cell approach, offering the prospect of complete and lasting remission.
Occurrences of cytokine release syndrome (CRS) and neurologic events (NEs) associated with Breyanzi in the study were mostly low grade. CRS, reported in 83% of patients, was predominantly mild to moderate, with no Grade 4/5 events.
Neurologic events were reported in 46% of patients, with the majority being low grade, although some Grade 3 events occurred.
This approval in providing new hope for patients with relapsed or refractory CLL or SLL. Patients, families, and researchers involved in advancing this important new treatment option.
