On May 30, 2024, BMS Announced FDA Approval of Breyanzi for the Treatment of Mantle Cell Lymphoma
On May 30, 2024, BMS Announced FDA Approval of Breyanzi for the Treatment of Mantle Cell Lymphoma
On May 30, 2024, Bristol Myers Squibb (BMS) announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel, liso-cel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
The approval was primarily based on data from the TRANSCEND NHL 001 study, which enrolled 88 patients with relapsed or refractory MCL who had received at least two prior lines of therapy. The results showed that among patients who received Breyanzi and were evaluable for efficacy (n=68), 85.3% (95% CI: 74.6-92.7) responded to the treatment, and 67.6% (95% CI: 55.2-78.5) achieved a complete response (CR). The median duration of response was 15.7 months (95% CI: 6.2-24.0), and the median progression-free survival was 15.3 months (95% CI: 6.6-24.9).
Regarding safety, Breyanzi demonstrated a consistent safety profile in clinical trials (n=702), with 54% of patients experiencing cytokine release syndrome (CRS) of any grade, including 3.2% with grade ≥3 CRS, and 31% reporting neurological events (NEs) of any grade, with 10% experiencing grade ≥3 NEs.
This is the third new indication for Breyanzi approved this year. Previously, on March 14th, the FDA granted accelerated approval for Breyanzi to treat adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had received at least two prior therapies, including a BTK inhibitor and a BCL-2 inhibitor.
On May 15th, the FDA also approved Breyanzi for adult patients with relapsed or refractory follicular lymphoma (FL) who had received at least two prior lines of systemic therapy.
Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy that was initially approved in the United States in February 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
The approval of this new indication for MCL marks the fourth non-Hodgkin’s lymphoma subtype for which Breyanzi has been approved, making it the CAR-T cell therapy approved for the broadest range of B-cell malignancies to date.
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