Health Canada approves GAZYVA™ (obinutuzumab), a medicine that harnesses the body's immune system to kill cancer cells, for patients with chronic lymphocytic leukemia (or CLL)
MISSISSAUGA, ON, Nov. 26, 2014 /CNW/ - For the nearly 2,200 Canadians diagnosed with Chronic Lymphocytic Leukemia (or CLL) — the most common form of adult leukemia1 — living with cancer can mean a life of infections, anemia, and even secondary cancers.2 CLL patients are at an increased risk of developing sarcoma (cancer of the bone or connective tissue), colorectal cancer and lung cancer among others.3
Today, Roche announced that Health Canada has approved GAZYVA™ (obinutuzumab) to be administered in combination with chlorambucil chemotherapy for the treatment of people with previously untreated CLL.4,5 GAZYVA™ directly targets the patient's disease and works with the body's immune system to kill cancer cells.6
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, making the condition difficult to treat.7,8
"While current treatment options are effective, they are quite aggressive, so CLL patients who are diagnosed later in life and are living with one or more comorbidities may be unable to tolerate these options," says Dr. Sue Robinson, a practicing hematologist at the QEII Health Sciences Centre in Halifax, Nova Scotia, and principal investigator for one of GAZYVA™'s clinical trial sites in Canada.
"The availability of GAZYVA™ now offers patients a new, targeted treatment that is administered with a mild form of chemotherapy for increased tolerability," says Dr. Robinson. "Physicians treating CLL patients need to consider not only the best way to fight the cancer, but also how to manage the other health conditions these patients are likely to have at their age. Balancing the efficacy of CLL treatments against the side effect profiles of these treatments is critical."
The combination of a novel antibody with a mild chemotherapy offers physicians the opportunity to treat CLL patients in a highly targeted manner without many of the side effects associated with more aggressive chemotherapy regimens.9 Clinical trials show that patients treated with GAZYVA™ live longer without their disease worsening than patients treated with chemotherapy alone.10
"Roche has been at the forefront of developing innovative, targeted therapies in hematology for the last 20 years," says Ronnie Miller, President and Chief Executive Officer, Roche Canada. "GAZYVA™ is the latest example of our commitment to understanding and responding to unmet patient needs. We remain committed to working in the best interest of patients and to bringing new treatments to market that will improve upon the current standards of care."
Jamie Muir, a former Member of the Nova Scotia Legislative Assembly (Truro-Bible Hill) was diagnosed with CLL in 2003 after he felt unusually fatigued during an election campaign.
"My doctor enrolled me in a clinical trial for GAZYVA™ and I have responded well," says Mr. Muir, who had open-heart surgery in 2012. "I believe it's important for people to know what treatment options are available to them, and I want to help educate others about CLL."
"GAZYVA™ in combination with chlorambucil has the potential to change the way CLL is treated in Canada," says Dr. Robinson.
About the Health Canada Approval of GAZYVA™
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 percent compared to chlorambucil alone (HR=0.16; p<0.0001).11 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 1 in 5 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.12
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), though this did not result in an increased rate of infections with GAZYVA™ treatment.
GAZYVA™ is a new monoclonal antibody designed to bind to CD20, a protein found on white blood cells called B cells.13 It attacks targeted cells both directly and together with the body's immune system.14,15 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. GAZYVA™ is also approved as a first-line treatment for CLL by the European Commission under the brand name GAZYVARO™.
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, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer 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 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. Roche Canada was founded in 1931. The company employs approximately 900 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario, and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.
1 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 October 15, 2014. Statistic from 2010.
2 Leukemia & Lymphoma Society of Canada. CLL Disease Complications. Available at http://www.llscanada.org/#/diseaseinformation/leukemia/chroniclymphocyticleukemia/diseasecomplications/. Accessed November 4, 2014.
3 Leukemia & Lymphoma Society of Canada.
4 GAZYVA™ Product Monograph. November 2014.
5 GAZYVA™ Product Monograph. November 2014.
6 GAZYVA™ Product Monograph. November 2014.
7 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.
8 Thurmes P, Call T, Slager S, et al.
9 GAZYVA™ Product Monograph. November 2014.
10 GAZYVA™ Product Monograph. November 2014.
11 GAZYVA™ Product Monograph. November 2014.
12 GAZYVA™ Product Monograph. November 2014.
13 GAZYVA™ Product Monograph. November 2014.
14 Goede V., Fischer K., Busch R., Engelke A., Eichhorst B., Wendtner C.M., … Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. January 8 2014; DOI: 10.1056/NEJMoa1313984.
15 Mossner E., Brunker P., Moser S., Puntener U., Schmidt C., Herter S., … Umana P. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell–mediated B-cell cytotoxicity. Blood. June 3 2010; 115(22):4393-4402.
SOURCE: Roche Canada
For further information: Jennifer Fox, Edelman, (416) 849-1958, Jennifer.Fox@edelman.com; Naziah Lasi-Tejani, Roche Canada, (905) 542-5598, email@example.com