AbbVie Announces Ontario and Quebec are First Provinces to Reimburse Subcutaneous EPKINLY™ (epcoritamab) for the Treatment of Diffuse Large B-Cell Lymphoma Under New Early Access Process

MONTREAL, Aug. 15, 2024 /CNW/ - AbbVie (NYSE: ABBV), today announced that EPKINLY is now listed on the Ontario Health (Cancer Care Ontario) formulary under the NDFP (New Drug Funding Program) and the HCTFP (High Cost Therapy Funding Program) programs¹ and the Régie de l'assurance maladie du Québec (RAMQ) Liste des médicaments - Établissements² for the treatment of adult patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) after two or more lines of systemic therapy and who have previously received or are unable to receive CAR-T cell therapy.

Information regarding the specific reimbursement criteria may be found by consulting the links below:

• Cancer Care Ontario Drug Formulary
• Régie de l'assurance maladie du Québec – Liste des médicaments - Établissements

This announcement comes approximately nine months after the submissions to CDA and INESSS, less than two months after the time-limited reimbursement (TLR) recommendation by Canada's Drug Agency and the recommendation from INESSS, and one month after the successful completion of the pan-Canadian Pharmaceutical Alliance (pCPA) Temporary Access Process (pTAP) negotiation, bringing a new treatment option to Canadians living with R/R DLBCL in an accelerated fashion.

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. However, subcutaneous single agent therapies are limited.^3,4,5

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.^6,7,8 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 X, Instagram, or LinkedIn.

References

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¹ Ontario Health (Cancer Care Ontario) formulary under the NDFP (New Drug Funding Program) and the HCTFP (High Cost Therapy Funding Program) programs. https://www.cancercareontario.ca/en/drugformulary/drugs/monograph/76651 Accessed August 14, 2024.

² Régie de l'assurance maladie du Québec. https://www.ramq.gouv.qc.ca/sites/default/files/documents/non_indexes/liste-med-etab-2024-08-14-fr.pdf Accessed August 14, 2024.

³ What is Lymphoma. Lymphoma Coalition. https://lymphomacoalition.org/what-is-lymphoma/. Accessed April 24, 2023.

⁴ Kanas G, Ge W, Quek RGW, et al. Leukemia & Lymphoma. 2022;63(1):54-63.

⁵ Crump M, Neelapu SS, Farooq U, et al. Blood. 2017;130(16):1800-1808.

⁶ 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.

⁷ 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

⁸ 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]