Nine Provinces Approve Accelerated Public Reimbursement of Diffuse Large B-Cell Lymphoma Treatment Under New Early Access Process

MONTREAL, Oct. 21, 2024 /CNW/ - AbbVie (NYSE: ABBV), today announced that nine (9) provinces have provided accelerated public coverage of EPKINLY™. EPKINLY is a treatment for adult patients with Relapsed or Refractory diffuse large B-cell lymphoma (R/R DLBCL) not otherwise specified, DLBCL transformed from indolent lymphoma, high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL) or follicular lymphoma Grade 3B (FLG3b) and is indicated after two or more lines of systemic therapy in patients who have previously received or are unable to receive CAR-T cell therapy.¹ EPKINLY has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit.

In August, EPKINLY was first listed, with specific reimbursement criteria, in Ontario and Quebec, and is now publicly funded in almost all remaining provinces, including Nova Scotia, British Columbia, Saskatchewan, Manitoba, and Newfoundland & Labrador.

"At AbbVie, we are dedicated to the well-being of patients and committed to providing innovative treatments to support their journey," said Rami Fayed, AbbVie's Vice President and General Manager in Canada. "It is humbling to see such widespread support for DLBCL patients to quickly access EPKINLY – demonstrating how urgently needed medicines can be brought to patients in a more timely manner."

"With almost all provinces onboard, urgent medicines can now be more accessible to patients with diseases such as R/R DLBCL across the country," said Antonella Rizza, CEO, Lymphoma Canada. "We commend the way all interested parties worked together to make this first accelerated reimbursement process a success – which ultimately means that physicians in these provinces can now prescribe this medicine to their patients through the provincial healthcare plans, eliminating the stress of waiting for access on patients and their families."

This announcement comes less than a year after the submissions to Canada's Drug Agency (CDA) and Quebec's INESSS (Institut national d'excellence en santé et services sociaux), mere months after the time-limited reimbursement (TLR) recommendation by CDA and the recommendation from INESSS, and very shortly after the successful completion of the pan-Canadian Pharmaceutical Alliance (pCPA) Temporary Access Process (pTAP) negotiation, more quickly bringing a treatment option to Canadians living with R/R DLBCL in almost all provinces.

DLBCL is a type of aggressive, fast-growing non-Hodgkin's lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell. DLBCL is the most common type of NHL. Although DLBCL is often curable, many patients are refractory to, or relapse after, first-line treatment with standard chemoimmunotherapy. For relapsed and refractory patients, several targeted therapies including T-cell mediated treatments have recently emerged.^2,3,4

About EPKINLY
EPKINLY is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody^® technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. It is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.^5,6,7 EPKINLY comes as a concentrate for solution, for SC injection, with each vial containing 4 mg in 0.8 mL (5 mg/mL) and a solution for SC injection, with each vial containing 48 mg in 0.8 mL (60 mg/mL) of epcoritamab.

Please consult the EPKINLY Product Monograph on this page.  

About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, gynecology and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Instagram or LinkedIn.

References

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¹ Epkinly (epcoritamab injection/for injection) product monograph. AbbVie Corporation. Available at: https://www.abbvie.ca/en/our-science/products.html. October 2023.

² What is Lymphoma. Lymphoma Coalition. https://lymphomacoalition.org/what-is-lymphoma/. Accessed April 24, 2023.

³ Kanas G, Ge W, Quek RGW, et al. Leukemia & Lymphoma. 2022;63(1):54-63.

⁴ Crump M, Neelapu SS, Farooq U, et al. Blood. 2017;130(16):1800-1808.

⁵ Engelberts PJ, Hiemstra IH, de Jong B, et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625.

⁶ Rafiq S, Butchar JP, Cheney C, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties." J. Immunol. 2013;190(6):2702-2711. DOI: 10.4049/jimmunol.1202588

⁷ Singh V, Gupta D, Almasan A. "Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." J Cancer Sci Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373.

SOURCE AbbVie Canada

Media Inquiries: Heather Neale, AbbVie Canada, [phone], [email protected]