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
|
_______________________________________________________
|
|
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