Bristol Myers Squibb (NYSE: BMY) has received regulatory acceptance from both the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for Breyanzi® (lisocabtagene maraleucel). In the U.S., the FDA accepted two supplemental Biologics License Applications (sBLA) from the company, expanding Breyanzi’s indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi). The FDA has granted Priority Review to both applications, setting a Prescription Drug User Fee Act (PDUFA) goal date of May 23, 2024, for relapsed or refractory FL and May 31, 2024, for relapsed or refractory MCL.
Japan’s MHLW has accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.
Anne Kerber, M.D., Senior Vice President, Head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb, stated, “Patients living with follicular lymphoma and mantle cell lymphoma often experience cycles of remission and relapse with multiple lines of treatment, and we are committed to delivering innovative treatment solutions to this population. Breyanzi offers the potential for durable response, and these filing acceptances in the U.S. and Japan support our commitment to delivering our best-in-class CAR T cell therapy treatments to as many eligible patients as possible.”
The regulatory applications for Breyanzi in FL and MCL are supported by clinical trial data. In relapsed or refractory FL, the applications are based on results from the TRANSCEND FL study, the largest clinical trial evaluating CAR T cell therapy in patients with relapsed or refractory indolent B cell non-Hodgkin lymphoma (NHL). Breyanzi demonstrated high rates of complete responses in this study. In relapsed or refractory MCL, the application in the U.S. relies on results from the MCL cohort of the TRANSCEND NHL 001 study, where Breyanzi demonstrated statistically significant and clinically meaningful responses in heavily pre-treated patients.
Both trials reported a consistent safety profile for Breyanzi, with no new safety signals. The results were presented at the 2023 International Conference on Malignant Lymphoma (ICML) in June 2023 and at the American Society of Hematology (ASH) Annual Meeting in December 2023.
Additionally, a sBLA for Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received a prior BTKi and B-cell lymphoma 2 inhibitor is currently under Priority Review with the FDA, with a target action date of March 14, 2024.