Columvi (glofitamab for injection) receives positive CADTH and INESSS recommendations for adult patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL)

2024-03-07

上市批准免疫疗法细胞疗法

The process for Canadians to access new medicines is complex and involves several different federal, provincial, and territorial agencies. As Roche Canada, we stand ready to work collaboratively to bring Columvi to Canadian patients who need it, as soon as possible. Positive recommendations from CADTH and INESSS are important steps towards public access to Columvi® (glofitamab for injection); provincial and territorial governments will make the final decision on public reimbursement.1,2 MISSISSAUGA, ON, March 7, 2024 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on March 5, 2024, the Institut National d'Excellence en Santé et en Services Sociaux (INESSS) recommended Columvi® (glofitamab for injection) for public reimbursement. This recommendation follows the recent positive recommendation from the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) issued on February 21, 2024. Reaching these important milestones is the result of close collaboration with both CADTH and INESSS and further emphasizes the need to move quickly through the subsequent steps to public reimbursement. Roche Canada now looks forward to working together with the pan-Canadian Pharmaceutical Alliance (pCPA), as well as the provincial and territorial governments, to achieve sustainable, equitable access for Canadian patients. Columvi is the only fixed treatment duration bispecific antibody authorized in Canada to treat diffuse large B-cell lymphoma.3,4,5 It received the first global marketing authorization when it was authorized by Health Canada almost one year ago on March 24, 2023. Since then, it has been authorized and publicly reimbursed in five other countries, and our aim is to ensure swift access to Columvi in Canada, as well. This recommendation shows that both CADTH and INESSS recognize the clinical evidence and benefit shown by Columvi for use in Canadians living with relapsed or refractory DLBCL relapsed or refractory DLBCL. In Canada, it is estimated that in 2023, 4,000 Canadians were diagnosed with diffuse large B-cell lymphoma.6,7,8 "It is exciting to see our continued progress towards public access to glofitamab, a targeted bispecific antibody treatment for Canadians living with relapsed or refractory DLBCL relapsed or refractory DLBCL," said Dr. John Kuruvilla, Hematologist in the Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre Cancer Centre. "This treatment is an important option to have available for patients that have received multiple prior treatments." "I am pleased to see INESSS and CADTH issue positive recommendations for glofitamab." said Dr. Nathalie Johnson, Hematologist at the Jewish General Hospital and Associate Professor at McGill University. "It is a fixed-duration treatment that could benefit patients with relapsed or refractory DLBCL relapsed or refractory DLBCL in Quebec and the rest of Canada." "The positive recommendations for this therapy are wonderful news for relapsed or refractory diffuse large B-cell lymphoma patients as we are one step closer to having public access to this treatment option." said Antonella Rizza, CEO, Lymphoma Canada. Columvi is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy.9 Full details on the recommendation, including conditions for reimbursement, are available on the CADTH and INESSS websites. About Columvi (glofitamab for injection)9 COLUMVI (glofitamab for injection) is a bispecific monoclonal antibody that binds bivalently (with high avidity) to CD20 expressed on the surface of B cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T cells. By simultaneous binding to CD20 on the B cell and CD3 on the T cell, COLUMVI mediates the formation of an immunological synapse with subsequent potent T-cell activation and proliferation, secretion of cytokines, and release of cytolytic proteins that results in the lysis of CD20-expressing B cells. COLUMVI comes as a concentrate for solution for infusion, with each vial containing either 2.5 mg (in 2.5 mL) or 10 mg (in 10 mL) of COLUMVI. Each mL contains 1 mg of COLUMVI. About Diffuse Large B-cell Lymphoma (DLBCL) Lymphoma is the name for a group of blood cancers that develop in your lymphatic system.10 Lymphomas occur in two main types: Hodgkin lymphoma and non-Hodgkin lymphoma. In particular, diffuse large B-cell lymphoma (DLBCL) is an aggressive (fast-growing) blood cancer and the most common form of non-Hodgkin lymphoma (NHL).11 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, where options may not offer optimal outcomes for patients and managing the disease can become complex.12 About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving personalized healthcare (PHC) forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec. For more information, please visit or follow Roche Canada on LinkedIn, or on X / Twitter @RocheCanada. SOURCE Roche Canada