- Following the signing of an agreement between AbbVie and the
pan-Canadian Pharmaceutical Alliance (pCPA), Ontario is the first province to reimburse
- VENCLEXTA is the first and only BCL-2 inhibitor to be approved
- A need exists for CLL patients who have failed novel oral
MONTREAL, May 23, 2019 /CNW/ - AbbVie (NYSE: ABBV), a
global, research and development-driven biopharmaceutical company,
announced today that Ontario is
the first province to reimburse VENCLEXTA® (venetoclax) monotherapy
under its Drugs and Devices Division's (DDD) Exceptional Access
Program effective May 13,
2019.ii VENCLEXTA is indicated for the treatment
of patients with chronic lymphocytic leukemia (CLL) who have
received at least one prior therapy and who have no other treatment
options. VENCLEXTA is an oral, once-daily medicine.
This listing follows the signing of an agreement between AbbVie
and the pan-Canadian Pharmaceutical Alliance (pCPA) earlier this
"People living with chronic lymphocytic leukemia in Ontario finally have access to VENCLEXTA,
which is great news considering the nature of this disease. When
faced with CLL, which can be recurrent, it is important to offer
physicians and their patients highly effective options to tackle
this illness," explains Elizabeth
Lye, Director of Research & Programs at Lymphoma Canada.
"At Lymphoma Canada, we hope that soon all Canadians will have
access to this treatment."
VENCLEXTA monotherapy will be available through the Exceptional
Access Program for the treatment of relapsed or refractory
chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL) in patients who have failed treatment with at least one prior
therapy (including B-cell receptor inhibitors) or who have
experienced intolerance to ibrutinib.
"When I meet a patient for the first time, I always explain that
CLL is a type of blood cancer that is chronic and that some may
relapse after being in remission. In fact, most of the patients I
see in my clinic have often already gone through another line of
treatment. Therefore, I want to ensure I have the appropriate
treatments available for my patients in a timely manner," says Dr.
Peter Anglin, MD, FRCPC, MBA,
Hematologist and Physician Lead, Stronach Regional Cancer Centre.
"I am thrilled that Ontario is the
first province to reimburse venetoclax; it's a positive step for
people living with CLL who need access to this much needed
CLL, which is typically a slow-progressing cancer of the bone
marrow and bloodiii, 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
"It's been a long time coming for wonderful news like this. I
can remember reading about clinical trials for this treatment
several years ago and thinking how promising it sounded for people
like me who have already been treated with more than one line of
therapy and relapsed," states Mark
Silverstein of Aurora,
Ontario. "Now it's finally here! Another treatment option in
the CLL world has been approved and reimbursed in the province of
Ontario, and hopefully soon coming
to every Canadian province. And thank you AbbVie for your
commitment to bringing VENCLEXTA to those who need it."
VENCLEXTA received a Notice of Compliance with
Conditions (NOC/c) from Health Canada on September 30, 2016. The therapy was approved as
monotherapy for previously treated CLL patients, who have either a
genetic mutation known as 17p deletion, or who do not have the
mutation but have no other available treatment options, and who
have received at least one other therapy. The 17p deletion is a
genetic mutation that is found in 3 to 10 percent of people with
previously untreated CLL and up to 50 percent of relapsed or
refractory cases.v Under Health Canada's NOC/c policy,
AbbVie will provide Health Canada with data from additional studies
to assess the clinical benefit of VENCLEXTA in these patient
"This agreement with the pCPA and subsequently the listing in
Ontario are positive steps towards
patients living with CLL accessing a medication that serves an
unmet medical need," stated Stéphane Lassignardie, General Manager
of AbbVie Canada. "AbbVie is committed to changing the way blood
cancers are treated with innovative new treatment options."
VENCLEXTA continues to be investigated in CLL and other
VENCLEXTA is being developed by AbbVie and Genentech, a member
of the Roche Group. It is jointly commercialized by the companies
in the U.S. and by AbbVie outside of the U.S.
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.
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.
et al. Long-Term Outcomes for Patients With Chronic Lymphocytic
Leukemia Who Discontinue IbrutinibCancer. 2017 Jun
ii Ontario Ministry of Health and
iii Lymphoma Canada. Chronic
lymphocytic leukemia. Available at
Accessed May 2019
iv Canadian Cancer Statistics.
Chronic lymphocytic leukemia statistics
Accessed May 2019
v Schnaiter A. et al. 17p deletion in
chronic lymphocytic leukemia: risk stratification and therapeutic
approachHematol Oncol Clin N Am. 2013;27:289–301
vi VENCLEXTA product monograph,
AbbVie Corporation. Date of Preparation: September 27, 2016. Date
of Revision: February 12, 2019
Accessed May 2019