Hoffmann-La Roche Limited (Roche Canada) announced that Health Canada has authorized POLIVY® (polatuzumab vedotin for injection) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.3
Lymphoma is the name for a group of blood cancers that develop in your lymphatic system, which is the system that works with other parts of your immune system to help your body fight infection and disease.4,5 In particular, large B-cell lymphomas comprise a wide spectrum of tumours that affect the B-cells of the lymphatic system.5,6 B-cells are responsible for making antibodies to fight bacteria, viruses and other foreign material such as fungi within the body.5
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL).7 It is estimated that in 2022, 11,400 Canadians will be diagnosed with non-Hodgkin lymphoma.1 DLBCL is a fast-growing, aggressive form of NHL.7 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.8 This situation is complicated further by the fact that currently the majority of disease relapse in 1L DLBCL occurs within the first 24 months after starting treatment. Overall, by introducing an additional treatment option for patients in this setting there is the potential to reduce the need for subsequent treatments and the associated patient burden of additional treatment.
"Lymphoma Canada is thrilled that there is a new frontline therapy available to patients diagnosed with diffuse large B cell lymphoma," said Antonella Rizza, Chief Executive Officer (CEO) of Lymphoma Canada. "As the most common form of Non-Hodgkin lymphoma, DLBCL impacts thousands of Canadians each year. With Health Canada approval of polatuzumab vedotin in combination with R-CHP, Canadian lymphoma patients have an alternative option available regarding their treatment."
POLIVY contains the active substance, polatuzumab vedotin, an anti-cancer agent, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. The monoclonal antibody part allows the substance to find and kill cancer cells in the body.3
"The initial management of LBCL remains a challenge," said Dr. Laurie Sehn, Chair of the Lymphoma Tumour Group at the BC Cancer Centre for Lymphoid Cancer, and Clinical Professor of Medicine in the Division of Medical Oncology at the University of British Columbia. "The POLARIX trial demonstrates a meaningful improvement in progression-free survival with the addition of polatuzumab vedotin and represents important progress in frontline therapy."
The Health Canada authorization is based on data from POLARIX, a Phase III, international, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics in 879 patients with previously untreated LBCL.3 The results of this study support the potential of POLIVY as an effective treatment option for people living with LBCL to improve progression-free survival with safety outcomes comparable with the standard of care.3
POLIVY currently has two approved indications in Canada. It has been previously authorized with conditions by Health Canada, in combination with bendamustine and rituximab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are not eligible for autologous stem cell transplant and have received at least one prior therapy.3
Roche is committed to working towards ensuring patient access to POLIVY, where this treatment may have the potential to benefit patients in Canada.
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