AbbVie Receives a Positive Reimbursement Recommendation from the Canadian Agencies for Drugs and Technology in Health pan-Canadian Oncology Drug Review Expert Review Committee for VENCLEXTA® in Combination with azacitidine for Acute Myeloid Leukemia Patients

  • 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

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.

_________________________

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

Cision View original content: https://www.newswire.ca/en/releases/archive/August2021/26/c9595.html

News Provided by Canada Newswire via QuoteMedia

The Conversation (0)
  BPH Global Ltd

120-Day Business Development Plan

The Board of BPH Global Ltd (ASX: BP8) (Company) announces that the Company’s CEO Matthew Leonard and CFO Chow Yee Koh are currently travelling in Malaysia and China for a series of meetings over a 2–3- week period commencing last week. The CEO and CFO will be joined by China-based Company Director Michael Huang for strategic meetings in Malaysia and China.

Keep reading...Show less
  BPH Global Ltd

BP8 to Expand Seaweed R&D Activities into Essential Mineral Extraction Utilising AI Search Technology; Carbon Credits

The Board of BPH Global Ltd (ASX: BP8) (Company) is pleased to announce that the Company is expanding the nature of its business to include the following projects:

Keep reading...Show less
Sirona Biochem Receives Commercial-Grade GlycoProteMim Based Anti-Aging Serum Formulations

Sirona Biochem Receives Commercial-Grade GlycoProteMim Based Anti-Aging Serum Formulations

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") announces a significant achievement in its quest to transform the skincare industry. Its subsidiary, TFChem, has successfully received formulations for its eagerly awaited GlycoProteMim™ based anti-aging serum from its formulation partner, Global Beauty Consulting (GBC). This marks a crucial step in Sirona Biochem's plan to offer innovative skincare solutions.

The chosen formulation will not only define the brand but also lay the foundation for a broader range of products. The team is in the process of selecting the precise formulation that will undergo standard safety evaluations and be used in the upcoming clinical trial. This is in preparation for the planned product launch in early 2025, ensuring compliance with regulatory standards in the European, US, and Canadian markets.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
double helix molecule with word "etf"

5 Small Biotech ETFs to Watch (Updated 2024)

Thanks to exchange-traded funds (ETFs), investors don’t have to be tied to one specific stock. Biotech ETFs allow market participants to gain leverage in multiple biotech companies via one investment vehicle.

The life science sector can certainly be risky, and ETFs are a good way to enter more safely than by investing in standalone stocks. A key advantage is that even if one company in the ETF takes a hit, the impact will be less direct.

Below the Investing News Network takes a look at five small biotech ETFs for investors to consider. They were selected using ETFdb.com, and their total assets under management (AUM) were under US$100 million as of March 8, 2024. All other figures were also current as of that date. Read on to learn more about these investment vehicles.

Keep reading...Show less

AMGEN PRESENTS NEW RESEARCH ON OTEZLA® AT AAD 2024

SPROUT 52-Week Data Demonstrate Durable Response and Consistent Safety Profile of Oral Otezla in Children with Moderate to Severe Plaque Psoriasis

Late-Breaking Phase 3 Study of Otezla in Palmoplantar Pustulosis Achieves Primary and Secondary Endpoints at 16 Weeks

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Collage with hands holding shiny DNA molecule on blue background.

5 Biggest Biotechnology ETFs in 2024

Investing in the biotech industry can be a long road to gains given the sector’s volatility.

Even with a good understanding of the system, no one can predict which treatment, device or therapy will give the biggest return, making biotech exchange-traded funds (ETFs) a more secure option than individual biotech stocks.

An ETF is a relatively safe investment route that can minimize losses while offering exposure to multiple companies instead of focusing on the gains and losses of a single biotech stock. With that in mind, here’s a brief look at the five top biotechnology ETFs by total assets. Data was sourced from ETFdb.com on March 1, 2024, and all data was current as of that time.

Keep reading...Show less

Latest Press Releases

Related News

×