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.
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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.
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3 What is
Lymphoma. Lymphoma Coalition.
https://lymphomacoalition.org/what-is-lymphoma/. Accessed April 24,
2023.
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4 Kanas G,
Ge W, Quek RGW, et al. Leukemia & Lymphoma.
2022;63(1):54-63.
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5 Crump M,
Neelapu SS, Farooq U, et al. Blood.
2017;130(16):1800-1808.
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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.
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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
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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.
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SOURCE AbbVie Canada