- INESSS recommends the reimbursement of VENCLEXTA®
(venetoclax) in combination with rituximab for the treatment of
adult patients with chronic lymphocytic leukemia
(CLL).i
- Adult patients with CLL taking VENCLEXTA in combination with
rituximab can stop their therapy after a defined treatment period
of 24 months on treatment.
MONTREAL, June 25, 2019 /CNW/ - AbbVie (NYSE: ABBV), a
global research and development-based biopharmaceutical
company, today announced that the Institut national d'excellence en
santé et en services sociaux (INESSS) recommends that the
Minister include Venclexta, in combination with rituximab, on the
Lists of Medications for the treatment of chronic lymphocytic
leukemia (CLL), if the following conditions are met: exceptional
medication and lessening of the economic
burden.i VENCLEXTA in combination with rituximab is
an effective treatment option that has the benefit of a finite
treatment approach, meaning patients are able to stop their therapy
after two years of treatment.
"Being able to prescribe a therapy, such as venetoclax in
combination with rituximab, that has a finite treatment
duration and manageable side effects is a welcomed option for my
patients. After two years, I can tell them that they can stop their
medication because this effective combination helps to delay
disease progression. So far, my clinical experience with venetoclax
plus rituximab has been remarkable," explains Dr. Sarit Assouline, Physician, Division of
Hematology, Sir Mortimer B. Davis-Jewish General Hospital, Senior
Investigator, Lady Davis Institute for Medical Research, Associate
Professor, Department of Oncology, McGill
University.
INESSS concludes that the evaluation of venetoclax's efficacy
and safety in combination with rituximab is based on a good-quality
study. The outcomes of that study demonstrated that venetoclax
delays disease progression compared to intravenous chemotherapy.
Although intravenous chemotherapy is not included on the Lists of
Medications, INESSS has recognized its
efficacy.i The most common adverse reactions with
venetoclax in combination with rituximab were related to white
blood cells. Furthermore, there is an unmet clinical need in CLL.
The reimbursement of venetoclax in combination with rituximab would
be beneficial in the care pathway of CLL
patients. i
"The INESSS recommendation for VENCLEXTA plus rituximab is
positive news for people living with CLL in Quebec," says Elizabeth Lye, Director of Research &
Programs, Lymphoma Canada. "Receiving a diagnosis of CLL or any
cancer is always shocking and overwhelming, therefore knowing that
there are highly effective treatments available provides
reassurance to people facing this uncertain journey."
CLL, which is typically a slow-progressing cancer of the bone
marrow and bloodii, is one of the most common types of
leukemia in adults. In Canada, CLL
accounts for approximately 2,465 newly diagnosed cases of leukemia
each year and is responsible for more than 600 deaths a
year.iii The goal of treatment is to delay progression
of the disease and improve quality of life.
"This is another tremendous milestone in our efforts to bring
VENCLEXTA plus rituximab to people living with CLL in Quebec. This is a much needed treatment
option as it is the first chemotherapy-free combination in CLL
that allows patients a 24-month treatment duration," says Stéphane
Lassignardie, General Manager of Abbvie Canada.
VENCLEXTA continues to be investigated in CLL and other
hematological diseases.
VENCLEXTA is being developed by AbbVie and Roche. It is jointly
commercialized by AbbVie and Genentech, a member of the Roche
Group, in the U.S. and by AbbVie outside of the U.S.
About the MURANO Study
A total of 389 patients with
R/R CLL who had received at least one prior therapy were enrolled
in the international, multicenter, open-label, randomized (1:1)
MURANO study (NCT02005471). The study was designed to evaluate the
efficacy and safety of VENCLEXTA in combination with rituximab (194
patients) compared with bendamustine in combination with rituximab
(195 patients). The median age of patients in the trial was 65
years (range 22-85).iv
About AbbVie Care
Canadians prescribed VENCLEXTA will
have the opportunity to be enrolled in AbbVie Care, AbbVie's
signature care program. The program is designed to provide a wide
range of customized services including reimbursement and financial
support, pharmacy services, lab work reminders and coordination,
personalized education and ongoing disease management support
throughout the treatment. For more information, please visit
www.abbviecare.ca.
About AbbVie
AbbVie is a global, research and
development-driven biopharmaceutical company committed to
developing innovative advanced therapies for some of the world's
most complex and critical conditions. The company's mission is to
use its expertise, dedicated people and unique approach to
innovation to markedly improve treatments across four primary
therapeutic areas: immunology, oncology, virology and
neuroscience. In more than 75 countries, AbbVie employees are
working every day to advance health solutions for people around the
world. For more information about AbbVie, please visit us at
www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie
on Twitter or view careers on our Facebook or LinkedIn page.
___________________________________________
i Institut national d'excellence en santé et en
services sociaux (INESSS). Avis à la Ministre.
www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Mai_2019/Venclexta_2019_05.pdf.
Accessed June 2019.
ii Lymphoma Canada. Chronic lymphocytic leukemia.
Available at
www.lymphoma.ca/lymphoma/lymphoma-101/types-lymphoma/cll. Accessed
June 2019.
iii Canadian Cancer Statistics. Chronic lymphocytic
leukemia statistics.
www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on.
Accessed June 2019.
iv VENCLEXTA product monograph, AbbVie Corporation. Date
of Preparation: September 27, 2016.
Date of Revision: February 12, 2019.
www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf.
Accessed June 2019.
SOURCE AbbVie