On May 30, 2024, FDA Approves Bristol Myers Squibb’s Breyanzi for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
On May 30, 2024, FDA Approves Bristol Myers Squibb’s Breyanzi for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
On May 30, 2024, Bristol Myers Squibb announced that the U.S. FDA has approved the expanded indication of its CAR-T therapy Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including those who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. According to the press release, Breyanzi is the first CAR-T therapy approved by the U.S. FDA for the treatment of four different subtypes of non-Hodgkin’s lymphoma, allowing it to treat a broad population of patients with B-cell malignancies.
The approval of Breyanzi was based on the results of the MCL cohort from the TRANSCEND NHL 001 trial, which enrolled adult patients with relapsed or refractory MCL who had received at least two prior lines of therapy, including a BTK inhibitor. Among the patients who received Breyanzi and were evaluated for efficacy (n=68), 85.3% achieved a response (95% CI: 74.6-92.7), with 67.6% achieving a complete response (95% CI: 55.2-78.5), as confirmed by the 2014 Lugano criteria and bone marrow biopsy. Patients achieved a rapid and durable response, with a median time to response of 1 month (range: 0.7-3), a median duration of response of 13.3 months (95% CI: 6.0-23.3), and a median follow-up of 22.2 months (95% CI: 16.7-22.8). More than half (51.4%; 95% CI: 37.5-63.7) of the responders remained in response at 12 months, and 38.8% (95% CI: 25-52.4) remained in response at 18 months.
Breyanzi demonstrated a consistent safety profile across clinical trials (n=702), with 54% of patients experiencing any-grade cytokine release syndrome (CRS), and 3.2% experiencing grade ≥3 CRS.
Breyanzi is an autologous CAR-T cell therapy targeting the CD19 antigen, with a defined composition and a 4-1BB costimulatory domain. It was initially approved by the FDA 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. Its unique feature is the controlled ratio of CD8-positive and CD4-positive T cells in the CAR-T cell product, which allows better management of cellular therapy-related toxicities. The 4-1BB signaling domain enhances the expansion and persistence of the CAR-T cells. Breyanzi received accelerated approval earlier this year for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and relapsed or refractory follicular lymphoma (FL).