CAR T Cell Therapy Breyanzi® (lisocabtagene maraleucel) Approved for Second-Line Relapsed or Refractory Diffuse Large B-cell Lymphoma

Breyanzi^® offers diffuse large B-cell lymphoma patients facing relapse or refractory disease earlier access with more personalized second-line treatment options.  

In the pivotal Phase 3 TRANSFORM trial, Breyanzi^® demonstrated a significant improvement in event-free survival over standard of care with a well-established and manageable safety profile.¹

MONTREAL, Jan. 13, 2025 /CNW/ - Bristol Myers Squibb Canada (BMS) is pleased to announce Health Canada's approval of Breyanzi^® (lisocabtagene maraleucel), a type of chimeric antigen receptor T cell (CAR T) therapy, for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and DLBCL arising from follicular lymphoma, who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, and who are candidates for autologous hematopoietic stem cell transplant (HSCT).¹ The Health Canada Notice of Compliance was received on September 25, 2024.

Canada's Drug Agency (CDA), formerly known as the Canadian Agency for Drugs and Technologies in Health (CADTH), and L'Institut national d'excellence en santé et en services sociaux in Quebec (INESSS), have issued positive recommendations for the reimbursement of Breyanzi^® as a second-line treatment.^2,3 Breyanzi^® is currently reimbursed as a third-line treatment in the provinces of Quebec and Ontario.

CAR T therapies are a personalized approach to treating certain blood cancers, using a patient's own T cells that are "reprogrammed" to recognize and attack cancer cells. This therapy is often a one-time treatment, delivered through a complex, patient-specific manufacturing process.⁴ CAR T therapies continues to work within the patient's body over time, with ongoing research showing it has led to meaningful, deep, and durable responses in cases where other treatments have failed.⁵

"Despite our efforts, around 30-40% of patients with DLBCL require second line treatment and with this approval, we now gain access to a new therapy which offers more patients a targeted approach," said Dr. John Kuruvilla, Hematologist, Princess Margaret Cancer Centre and Professor of Medicine, University of Toronto. "Breyanzi^® delivers improved outcomes over the previous decades-old standard of second-line care, underscoring the benefits of using CAR T cell therapy earlier for patients with relapsed or refractory DLBCL."⁶ 

Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive fast-growing form of B-cell non-Hodgkin lymphoma (NHL) and constitutes 30-40% of all Canadian NHL cases.⁶ It affects immune cells called B lymphocytes, which are a type of white blood cell. DLBCL typically starts as a quick growing mass in a lymph node, although, it can also start in other areas of the body such as the intestines, bones, brain, or spinal cord. 

"We are thrilled to see a CAR T therapy option approved as a second-line treatment for Canadians living with relapsed or refractory DLBCL," said Antonella Rizza, CEO, Lymphoma Canada. "This approval marks a significant step forward in improving survival and quality of life for patients, aligning with our commitment to support advancements that empower individuals and families affected by lymphoma."

The Health Canada approval is supported by results from the pivotal Phase 3 TRANSFORM trial, where Breyanzi^® showed statistically significant and clinically meaningful improvements in event free survival (EFS), the study's primary endpoint as well as complete response (CR) and progression-free survival (PFS) in key secondary endpoints. Compared to standard therapy which consists of salvage immunochemotherapy followed by high-dose chemotherapy and hematopoietic stem cell transplant (HSCT), Breyanzi^® delivered enhanced outcomes with a well-established and manageable safety profile.¹ 

"Driven by a commitment to improve patient outcomes, we are pleased Health Canada has approved Breyanzi^® as a second-line treatment. This milestone highlights our commitment to advancing patient care through innovative therapies like CAR T and other targeted treatments," said Elaine Phillips, General Manager, BMS Canada. "Our mission to transform lives has already and continues to provide hundreds of thousands of patients with effective options that once didn't exist. Today's announcement empowers us to continue to reshape cancer care and offer hope to those facing serious diseases."

For more information about Breyanzi^®, including prescribing and safety information, please consult the product monograph here.

About Bristol Myers Squibb Canada Co.

Bristol Myers Squibb Canada Co. is an indirect wholly-owned subsidiary of Bristol Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol Myers Squibb Canada Co. employs close to 300 people across the country. For more information, please visit www.bms.com/ca/en.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

___________________________

¹ Breyanzi^® (lisocabtagene maraleucel) Product Monograph. September 25, 2024. https://www.bms.com/assets/bms/ca/documents/productmonograph/BREYANZI_EN_PM.pdf

² Canada's Drug and Health Technology Agency. CADTH Reimbursement Recommendation . Cda-amc.ca. December, 2024. https://www.cda-amc.ca/sites/default/files/DRR/2024/PG0358-Breyanz_FINAL_REC.pdf 

³ Institut national d'excellence en santé et en services sociaux. INESSS Avis au ministre. Inesss.qc.ca. January, 2025. https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Janvier_2025/Breyanzi_LGCB_2024_12.pdf

⁴ Lymphoma Canada. CAR T-Cell Therapy: A Revolutionary Treatment for Non-Hodgkin Lymphoma. Lymphoma.ca. https://www.lymphoma.ca/lymphoma/non-hodgkin-lymphoma/car-t-therapy/

⁵ Leukemia & Lymphoma Society of Canada. CAR T-CELL Therapy. August 8, 2023. Bloodcancers.ca. https://www.bloodcancers.ca/sites/default/files/2021-11/LLS1154-F-FS-CAR-T-4P-E04%20Final%20with%20sponsor%20logos.pdf

⁶ Lymphoma Canada. CANADIAN EVIDENCE-BASED GUIDELINE For the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Lymphoma.ca. September 2021.  https://www.lymphoma.ca/wp-content/uploads/2021/09/LymphomaCanada_Guideline_Relapsed_Refractory_DLBCL_VF_Digital.pdf

SOURCE Bristol-Myers Squibb Canada

For media requests please contact: Daphne Weatherby, Corporate Affairs, Bristol Myers Squibb Canada, [email protected]