AbbVie Receives Positive Recommendation from the Pan-Canadian Oncology Drug Review for VENCLEXTA™ — an Oral Therapy for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)

• pCODR conditionally recommends the reimbursement of VENCLEXTA for the treatment of patients with CLL who have received at least one prior therapy and who have failed a BCRiⁱ

• VENCLEXTA is the first and only approved BCL-2 inhibitor in Canada
• A need exists for CLL patients who have failed novel oral therapiesⁱⁱ

MONTREAL, March 6, 2018 /CNW/ — AbbVie, a global research and development-based biopharmaceutical company, today announced that the pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee conditionally recommends the reimbursement of VENCLEXTA™ for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have failed a BCRi. This recommendation is a positive step towards patients living with CLL accessing a medication that serves an unmet medical need.

VENCLEXTA is a first-in-class, oral, once-daily medicine. It selectively inhibits the BCL-2 protein, which is responsible for helping cancer cells survive in the blood.

"Lymphoma Canada understands the high relapse rate of CLL that necessitates a variety of treatment options. The positive recommendation of VENCLEXTA provides Canadians living with CLL with hope for the future, which is an important determinant as one battles this disease," says Robin Markowitz, CEO, Lymphoma Canada. "Lymphoma Canada is confident that the pan-Canadian Oncology Drug Review Expert Review Committee's decision to recommend VENCLEXTA for reimbursement will provide patients with comfort to know that they have additional treatment options."

VENCLEXTA product shot courtesy of AbbVie (CNW Group/AbbVie Canada)

CLL, which is typically a slow-progressing cancer of the bone marrow and blood ⁱⁱⁱ, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 2,200 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.^iv 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 Despite the development of new therapies for relapse/refractory (R/R) CLL, there remains a need for salvage therapies for patients that have failed treatment because they have relapsed, are refractory or simply intolerant or unsuitable to the toxicity profile of these newer agents. ⁱⁱ

"The first thing I understood during my initial consultation with my Hematologist about my leukaemia is that it was chronic. Since my diagnosis in 2010, I have relapsed twice, but I have always been fortunate that the right treatment was available to me at the right time," explains Mark Silverstein of Aurora, ON. "This last relapse was no different, and the treatment I had been excited about for several years was made available only a couple of months prior to my second relapse. Now with VENCLEXTA, Canadians living with CLL have another treatment option. I have chosen my own way over the last seven years - by educating myself on my disease, maintaining a healthy partnership with my Hematologist, by removing fear from my choices, and finally to consistently remain intellectually, emotionally, and spiritually open to a journey with no assurances how it will all turn out."

VENCLEXTA previously received a Notice of Compliance with Conditions (NOC/c) by Health Canada on September 27, 2016. The therapy has been approved for previously treated chronic lymphocytic leukemia (CLL) patients, who have either a genetic mutation, known as 17p deletion, or no other available treatment options. Under NOC/c policy, AbbVie will provide Health Canada with data from additional studies to confirm the clinical benefit of VENCLEXTA.^vi

"For people living with CLL, the goal of treatment is to delay progression of the disease and improve quality of life. Therefore, providing Canadians access to an approved treatment option is essential. The entire team at AbbVie Canada applauds and celebrates the pan-Canadian Oncology Drug Review recommendation for VENCLEXTA," said Stéphane Lassignardie, General Manager of Abbvie Canada. "This recommendation reinforces AbbVie's growing position in hematologic oncology."

VENCLEXTA continues to be investigated in CLL and other hematological diseases.

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.

Contact
Muriel Haraoui
Email: muriel.haraoui@abbvie.com
Tel: 514.717.3764