- pERC recommends reimbursement of VENCLEXTA® (venetoclax) in
combination with azacitidine for the treatment of newly diagnosed
acute myeloid leukemia (AML) who are ineligible for intensive
induction chemotherapy.
- The VIALE-A trial demonstrated a statistically significant
increase in overall survival with VENCLEXTA® in combination with
azacitidine compared to placebo in combination with azacitidine
alone.1
- AML is one of the most difficult-to-treat blood cancers with a
very low survival rate.2,4
MONTREAL,
Aug. 26, 2021 /CNW/ -
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical
company, announced today that the CADTH pCODR Expert Review
Committee (pERC) recommends that VENCLEXTA® (venetoclax) in
combination with azacitidine should be reimbursed for the treatment
of patients with newly diagnosed acute myeloid leukemia (AML) who
are 75 years or older, or who have comorbidities that preclude use
of intensive induction chemotherapy, only if the conditions listed
are met.3 AML is an aggressive and difficult-to-treat
blood cancer with a low survival rate.2,4 In
Canada, the five-year net survival rate is approximately 21% for
people diagnosed with AML in the general
population.4
"AML is one of the most common types of leukemia in adults. This
cancer progresses rapidly and has a significantly lower survival
rate compared to other cancers," said Dr. Joseph Brandwein, Hematology Division Director
and Professor in the Department of Medicine at the University of Alberta. "The average age is nearly
70, and most older AML patients are not candidates for intensive
chemotherapy and stem cell transplantation. For those patients,
treatments to date have not been very effective. This new regimen
has demonstrated improved outcomes."
Overall, pERC concluded that venetoclax plus azacitidine
provides a treatment option for older patients and patients with
comorbidities that has an impact on the disease and improves
survival.3
"I was diagnosed in November 2019
with AML and my treatment plan included VENCLEXTA. I am hopeful
that newly diagnosed AML patients will soon have access to this
treatment," said William Levine of
Courtice, Ontario.
In the VIALE-A trial, the median overall survival of patients
who received VENCLEXTA plus azacitidine was 14.7 months (95% CI,
11.9, 18.7) vs 9.6 months (95% CI, 7.4, 12.7) in patients who
received azacitidine in combination with placebo. In the VENCLEXTA
plus azacitidine arm, the most frequent serious adverse reactions
(≥ 5%) were febrile neutropenia (30%), pneumonia (23%), sepsis
(16%) and hemorrhage (9%).1
"We have reached another important milestone. With this positive
recommendation by the pCODR Expert Review Committee, we are one
step closer to providing this treatment to all Canadians who need
it. At AbbVie, we stand by our mission to transform the standard of
care for people living with cancer," said Tracey Ramsey, Vice President and General
Manager, AbbVie Canada.
VENCLEXTA in combination with azacitidine was approved by
Health Canada in December 2020.
Health Canada's approval was
granted under Project Orbis, an FDA initiative which provides a
framework for concurrent submission and review of oncology products
among international partners.
Venetoclax 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 AbbVie in Oncology
At AbbVie, we strive to
discover and develop medicines that deliver transformational
improvements in cancer treatment by uniquely combining our deep
knowledge in core areas of biology with cutting-edge technologies,
and by working together with our partners – scientists, clinical
experts, industry peers, advocates, and patients. We remain focused
on delivering these transformative advances in treatment across
some of the most debilitating and widespread cancers. We are also
committed to exploring solutions to help patients obtain access to
our cancer medicines. AbbVie's oncology portfolio consists of
marketed medicines and a robust pipeline containing multiple new
molecules being evaluated worldwide in more than 300 clinical
trials and more than 20 different tumor types.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines 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, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.ca. Follow
@abbviecanada on Twitter or find us on Facebook, Instagram, YouTube
and LinkedIn.
_________________________
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1 AbbVie
Corporation Venclexta(R) (venetoclax) Product Monograph. Date of
Preparation: September 27, 2016. Date of Revision: January 21,
2021.
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf.
Accessed August 26, 2021.
|
2 Leukemia
& Lymphoma Society of Canada. Acute myeloid leukemia (AML).
https://www.llscanada.org/leukemia/acute-myeloid-leukemia. Accessed
August 26, 2021.
|
3 CADTH.
https://www.cadth.ca/venetoclax. Accessed August 26,
2021.
|
4 Canadian Cancer Society. Survival
statistics for acute myelogenous leukemia.
https://www.cancer.ca/en/cancer-information/cancer-type/leukemia-acute-myelogenous-aml/prognosis-and-survival/survival-statistics/?region=on.
|
SOURCE AbbVie Canada