Health Canada issues AbbVie a Notice of Compliance for chronic lymphocytic leukemia

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Health Canada issues a Notice of Compliance for AbbVie Venclexta (venetoclax) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have had at least one prior therapy.

“Having another effective therapy for relapsed/refractory CLL is a great benefit to patients.  It is also valuable to have this new therapy be of fixed duration because most patients prefer not to have to remain on therapy indefinitely,” explains Dr. Carolyn Owen, MD, MDres(UK), FRCPC, a hematologist and associate professor at the University of Calgary. “With venetoclax plus rituximab, I can now offer my patients an effective treatment with a clear end-date, allowing patients to plan for the future and enjoy time off therapy.”

The approval is based on the Murano Phase 3 clinical trial data which demonstrated a significant improvement in progression-free survival (PFS, the time on treatment without disease progression or death) for relapsed/refractory (R/R) CLL patients, reducing the risk of disease progression or death by 81 percent when compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy regimen.i

“Lymphoma Canada is pleased with the approval of Venclexta in combination with rituximab for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is imperative to offer patients effective treatment options so that they can face their cancer journey with the comfort of knowing that there are always alternatives,” says Elizabeth Lye, scientific advisor, Lymphoma Canada.

Clinical trial patients who received Venclexta plus rituximab achieved an overall response rate (ORR) of 92 per cent and those who received the bendamustine plus rituximab regimen achieved an ORR of 72 per cent. The most common adverse reactions (ARs), greater than or equal to 20 per cent, with a 5 per cent higher frequency reported with Venclexta in combination with rituximab were neutropenia, diarrhea and upper respiratory tract infection.

“When my CLL relapsed for the second time, I was fortunate to have access to Venclexta in combination with rituximab,” explains Mark Silverstein of Aurora, ON. “Today, I am able to enjoy an improved quality of life, and do what brings a great deal of meaning to my life: to help others navigate through their cancer journey with confidence and dignity by encouraging them to advocate for themselves within the health care system, reflect on the potential benefits in understanding their cancer and treatment landscape, to assist in managing the emotional and spiritual effects of a diagnosis, and finally to help them find what is meaningful in their own lives.”

In Canada, CLL accounts for approximately 2,400 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year. Venclexta helps to delay progression of the disease and improve quality of life.

” Venclexta plus rituximab is the first chemotherapy-free combination in CLL that allows patients a 24-month treatment duration,” says Stéphane Lassignardie, general manager of Abbvie Canada. “The approval of this regimen will bring a much needed treatment option to Canadians living with CLL.”

Venclexta 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.

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