Quebec becomes the first province to fund GAZYVA® for patients with most common form of leukemia[1]

Targeted treatment to be added to Quebec's drug benefit formulary for patients with Chronic Lymphocytic Leukemia  

MISSISSAUGA, ON, June 2, 2015 /CNW/ - People in Quebec living with Chronic Lymphocytic Leukemia (CLL) will now be able to access a new treatment option through the province's prescription drug insurance plan. Just yesterday, GAZYVA^® (obinutuzumab) in combination with chlorambucil chemotherapy was added to Quebec's Hospital Formulary. GAZYVA^® was approved by Health Canada on November 25, 2014, in combination with chlorambucil, for the treatment of patients with previously untreated CLL.²

"We are pleased to hear about the Minister of Health's decision to make GAZYVA^® available to CLL patients," said Mr. Ronnie Miller, president and CEO, Roche Canada. "As a leader in oncology, Roche is committed to not only developing breakthrough treatments for patients, but also collaborating with key stakeholders within the healthcare system to ensure that patients have access to those medications."

CLL is the most common form of adult leukemia, with nearly 2,200 Canadians diagnosed each year.^3,4 It is an incurable, slow-growing cancer of the blood and bone marrow.⁵  Since the average age of diagnosis for CLL is 72 years, nearly 90 per cent of patients are living with at least one comorbidity (e.g., cardiac disease, diabetes or respiratory disease), which may be associated with their age and lifestyle, potentially limiting their treatment options.⁶

GAZYVA^®, a novel anti-CD20,⁷ combined with a mild chemotherapy works by directly targeting the patient's disease and working with the body's immune system to kill cancer cells.

Funding for GAZYVA^® continues to be under review in all other Canadian provinces.

About GAZYVA^®
GAZYVA^® is a monoclonal antibody designed to bind to CD20, a protein found on white blood cells called B cells. It attacks targeted cells both directly and together with the body's immune system. GAZYVA^® was designed by Roche Glycart AG, a wholly-owned, independent research unit of Roche and is the first medicine approved under the U.S. Food and Drug Administration's (FDA) Breakthrough Drug designation.⁸ GAZYVA^® is also approved as a first-line treatment for CLL by the European Commission under the brand name GAZYVARO™.

Health Canada's approval of GAZYVA^® is based on results from the pivotal Phase III CLL11 trial, which was a multicenter, open-label, randomized three-arm study enrolling 781 patients with previously untreated CLL and co-existing medical conditions.

The CLL11 trial was conducted in cooperation with the German CLL Study Group (GCLLSG) and investigated the efficacy, as well as safety profile of either GAZYVA^® plus chlorambucil or RITUXAN^® (rituximab) plus chlorambucil compared to chlorambucil alone. The trial showed that people who received GAZYVA^® in combination with chlorambucil significantly reduced the risk of disease progressions or death by 84 per cent compared to chlorambucil alone (HR=0.16; p<0.0001). GAZYVA^® also more than doubled the time people with newly diagnosed CLL lived without the disease getting worse (median progression-free survival (PFS): 23.0 months vs. 11.1 months). Approximately one in five patients (or 22 per cent) receiving GAZYVA^® in combination with chlorambucil achieved a complete response (CR), which is the disappearance of all signs of cancer in response to treatment. ⁹

The most common Grade 3/4 adverse events for those who received GAZYVA^® in combination with chlorambucil compared to chlorambucil alone were infusion-related reactions during the first infusion (21 per cent vs. 0 per cent [chlorambucil is an oral medicine]), low platelet count (thrombocytopenia, 11 per cent vs. 3 per cent) and low count of certain types of white blood cells (neutropenia, 34 per cent vs. 16 per cent).² 

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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Disclaimer: Cautionary statement regarding forward-looking statements
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References
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^1	The Leukemia and Lymphoma Society of Canada. Disease information and support. http://www.llscanada.org/diseaseinformation/getinformationsupport/factsstatistics/leukemia/. Accessed on May 29, 2015.
^2	GAZYVA^®Product Monograph. November 2014.
^3	The Leukemia and Lymphoma Society of Canada. Disease information and support. http://www.llscanada.org/diseaseinformation/getinformationsupport/factsstatistics/leukemia/. Accessed on May 29, 2015.
^4	Canadian Cancer Society. Chronic Lymphocytic Leukemia. Chronic lymphocytic leukemia statistics. https://www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed May 29, 2015.
^5	Canadian Cancer Society. Chronic Lymphocytic Leukemia. Disease progression of chronic lymphocytic leukemia. https://www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/diseaseprogression/?region=on. Accessed May 29, 2015.
^6	Thurmes P, Call T, Slager S, et al. Comorbid conditions and survival in unselected, newly diagnosed patients with chronic lymphocytic leukemia. Leuk Lymphoma. 2008;49(1):49-56.
^7	Shah A. Obinutuzumab: a novel anti-CD20 monoclonal antibody for previously untreated chronic lymphocytic leukemia.        Ann Pharmacother. 2014 Oct;48(10):1356-61. http://www.ncbi.nlm.nih.gov/pubmed/25037849. Accessed June 1, 2015.
^8	U.S. Food and Drug Administration. (2013). FDA approves Gazyva for chronic lymphocytic leukemia [Press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373209.htm. Accessed June 1, 2015.
^9	Goede V, Fischer K, Busch R, et al. Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10.

SOURCE Roche Canada

Kate Hanna, Roche Canada, 905-285-7729, [email protected]; Jessica Gaulin, Edelman, 514-315-8370, [email protected]

Related Links

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