Pharma Focus Asia

Bristol Myers Squibb's Breyanzi Receives Regulatory Approval in the U.S. and Japan for Relapsed or Refractory Follicular Lymphoma and Relapsed or Refractory Mantle Cell Lymphoma

Wednesday, January 31, 2024

Bristol Myers Squibb (NYSE: BMY) has recently gained regulatory approval from both the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for its CAR T cell therapy, known as Breyanzi® (lisocabtagene maraleucel). The FDA has accepted two supplemental Biologics License Applications (sBLA) for Breyanzi to broaden its indications. Specifically, it is intended for the treatment of adult patients dealing with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi). These applications have been granted Priority Review, with Prescription Drug User Fee Act (PDUFA) goal dates of May 23, 2024, for FL and May 31, 2024, for MCL.

Simultaneously, the MHLW in Japan has accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.

Dr. Anne Kerber, Senior Vice President, Head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT) at Bristol Myers Squibb, emphasized the commitment to providing innovative treatment solutions for patients dealing with follicular lymphoma and mantle cell lymphoma. Breyanzi has shown potential for a durable response, and the regulatory acceptances in both the U.S. and Japan underscore the company's dedication to making CAR T cell therapy accessible to eligible patients.

The regulatory submissions are supported by data from the TRANSCEND FL study for FL and the MCL cohort of the TRANSCEND NHL 001 study for MCL. These studies demonstrated high rates of complete responses with a consistent safety profile, and the results were presented at the 2023 International Conference on Malignant Lymphoma (ICML) and the American Society of Hematology (ASH) Annual Meeting in June and December 2023, respectively.

Apart from FL and MCL, a supplemental Biologics License Application (sBLA) for Breyanzi is also under Priority Review by the FDA 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, with a target action date of March 14, 2024.

Breyanzi, a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, has already received FDA approval for the treatment of certain types of lymphomas, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal DLBCL, and follicular lymphoma grade 3B, in specific patient populations. It is made from a patient’s own T cells, genetically reengineered to become CAR T cells, and is administered via infusion as a one-time treatment.



magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopNitrosamine Advance Workshop 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024