- pERC conditionally recommends reimbursement of
VENCLEXTA® (venetoclax) in combination with rituximab
for the treatment of adult patients with chronic lymphocytic
leukemia (CLL) who have received at least one prior
therapy.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 6, 2019 /CNW/ - AbbVie (NYSE: ABBV), a
global research and development-based biopharmaceutical
company, today announced that the pan-Canadian Oncology Drug
Review (pCODR) Expert Review Committee (pERC) conditionally
recommends reimbursement of VENCLEXTA® (venetoclax) in combination
with rituximab for the treatment of adult patients with chronic
lymphocytic leukemia (CLL) who have received at least one prior
therapy, irrespective of their 17p deletion status, only if the
following condition is met: cost-effectiveness being improved to an
acceptable level.i VENCLEXTA in combination with
rituximab is an effective treatment option that has the benefit of
a finite treatment approach, meaning patients can able to stop
their therapy after two years of treatment.
"With venetoclax plus rituximab, patients receive a highly
effective treatment that leads to durable remission while having a
clear defined end-date. The concept of finite treatment duration is
something my patients appreciate because they have the ability to
be off therapy," says Dr. Carolyn
Owen, MD, MDres(UK), FRCPC, a Hematologist and associate
professor at the University of
Calgary.
pERC concluded in its report that VENCLEXTA plus rituximab
aligns with patient values in that it provides additional treatment
choice, delays disease progression, has manageable side effects, a
finite treatment duration, and a partially oral route of
administration.i
"The pCODR recommendation for VENCLEXTA plus rituximab is
positive news for Canadians living with CLL," 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 Canadians living with CLL. 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 and beyond. 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
|
pan-Canadian Oncology Drug Review (pCODR) Expert
Review Committee (pERC) final recommendation.
www.cadth.ca/sites/default/files/pcodr/Reviews2019/10162VenetoclaxRituximabCLL_FnRec_approvedbyChair_REDACT_Post_31May2019-final.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