AbbVie Announces First Provincial Reimbursements for VENCLEXTA® (venetoclax) in Combination with Azacitidine for Acute Myeloid Leukemia (AML) Patients

• Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA), Quebec, Saskatchewan, and Manitoba are the first provinces to reimburse the combination treatment for newly diagnosed acute myeloid leukemia (AML) patients who are ineligible for intensive induction chemotherapy.

MONTREAL, Feb. 10, 2022 /CNW/ - AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that an agreement was reached with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA^® (venetoclax) in combination with azacitidine 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.ⁱ

Effective February 2^nd, on Québec's Liste des medicaments-établissements, effective February 1^st on Saskatchewan Cancer Agency drug formulary, and effective February 24^th on Manitoba's Drug Benefits and Interchangeability Formulary, VENCLEXTA is listed in combination with azacitidine, for first line treatment of patients with newly diagnosed AML who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. For full criteria, consult the list of medications in effect.^{ii, iii, iv}

"Acute myeloid leukemia is a blood cancer with a survival rate that still needs to be improved. Intensive chemotherapy treatments lead to toxicity, which can limit their use. However, our understanding of this disease has improved considerably over the past few years and, thanks to new treatment options such as the combination of venetoclax and azacitidine, we are now able to effectively treat a greater proportion of patients," explains Dr. Julie Bergeron, MD, FRCPC, associate clinical professor, head of the Optilab CHUM cluster of hematology laboratories, and hematologist at the CEMTL Maisonneuve-Rosemont facility.

In Canada, the five-year net survival rate is approximately 21% for people diagnosed with AML in the general population. ^v

"Every day, we aim to transform the standard of care in Oncology. Having effective and proven treatment options is vital for patients and their families impacted by AML. It is great news that VENCLEXTA plus azacitidine is now reimbursed in Quebec, Saskatchewan and Manitoba for people living with AML," says Tracey Ramsay, 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 accelerated review of oncology products among international partners.

VENCLEXTA 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 LinkedIn.

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i} 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 February 3, 2022.

ⁱⁱ Régie de l'assurance maladie du Québec. https://www.ramq.gouv.qc.ca/sites/default/files/documents/liste_med_etab_2022-02-02.pdf . Accessed February 3, 2022.

ⁱⁱⁱ Saskatchewan Cancer Agency. http://www.saskcancer.ca/images/pdfs/health_professionals/drug_formulary/drug_formulary/SCA_Drug_Formulary_-_2022-02-01.pdf. February 3, 2022.

^iv Manitoba Health. Manitoba Drug Benefits and Manitoba Drug Interchangeability Formulary Amendments. https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin116.pdf. Accessed February 3, 2022.

^v Canadian Cancer Society. Survival statistics for acute myelogenous leukemia. https://cancer.ca/en/cancer-information/cancer-types/acute-myelogenous-leukemia-aml/prognosis-and-survival/survival-statistics. Accessed February 3, 2022.

SOURCE AbbVie Canada

Media: Muriel Haraoui, AbbVie Canada, 514-717-3764, [email protected]