On May 16, 2024, the U.S. FDA Granted Accelerated Approval for Expanded Indication of Breyanzi for Follicular Lymphoma
On May 16, 2024, the U.S. FDA Granted Accelerated Approval for Expanded Indication of Breyanzi for Follicular Lymphoma
On May 16, 2024, the U.S. Food and Drug Administration (FDA) announced accelerated approval for the expanded indication of Breyanzi, Bristol Myers Squibb’s CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This comes after Breyanzi received accelerated approval from the FDA in March of this year for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).
This accelerated approval is based on the positive results from the phase 2 TRANSCEND-FL clinical trial. In this single-arm, open-label clinical trial, patients treated with Breyanzi achieved an overall response rate (ORR) of 95.7% (95% CI: 89.5%, 98.8%) at a median follow-up of 16.8 months, with the median duration of response not yet reached (95% CI: 18.04, NR).
FL is the second most common indolent form of non-Hodgkin lymphoma (NHL), accounting for 20% to 30% of all NHL cases. Most FL patients are diagnosed after the age of 50. In FL, white blood cells accumulate in the lymph nodes or organs, forming tumors. FL is characterized by alternating periods of remission and relapse, and treatment becomes more challenging after the disease relapses or progresses.
Breyanzi is an autologous CAR-T cell therapy targeting the CD19 antigen. It received FDA approval 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. A unique feature of this therapy is the controlled ratio of CD8-positive and CD4-positive T cells in the CAR-T cell product, which can better manage the toxicity associated with cell therapy. The 4-1BB costimulatory domain used in the chimeric antigen receptor enhances the expansion and persistence of CAR-T cells.
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