Benzinga | Aug 26, 2021 10:03AM EDT

AbbVie Receives Reimbursement Recommendation from Canadian Agencies for Drugs and Technology in Health (CADTH) pan-Canadian Oncology Drug Review Expert Review Committee (pERC) for VENCLEXTA (venetoclax) with azacitidine for Acute Myeloid Leukemia Patient

AbbVie (NYSE:ABBV), a research-based global biopharmaceutical company, announced today that the CADTH pCODR Expert Review Committee (pERC) recommends that VENCLEXTA(r) (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.