Health Canada Approves GAZYVA® for Patients with Previously Treated Follicular Lymphoma

New targeted treatment now available for Canadians living with the most common form of slow-growing, non-Hodgkin's lymphoma

MISSISSAUGA, ON, Feb. 7, 2017 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) today announced that Health Canada has approved GAZYVA® (obinutuzumab) in combination with bendamustine followed by GAZYVA monotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a RITUXAN® (rituximab)-containing regimen.1  

Each year, an estimated 2,800 Canadians are diagnosed with follicular lymphoma,2 a slow-growing form of non-Hodgkin's lymphoma.3 While chemotherapy and targeted treatments such as RITUXAN – the current standard of care – have improved survival rates for patients impacted by the disease,4 follicular lymphoma often recurs.5

"Despite significant improvements in the treatment of follicular lymphoma including the addition of rituximab to primary chemotherapy and the use of rituximab maintenance, follicular lymphoma remains an incurable disease," said Dr. John Kuruvilla, a hematologist at Princess Margaret Hospital and Associate Professor at the University of Toronto. "New treatment options are needed for Canadians dealing with relapsed or refractory follicular lymphomas. GAZYVA in combination with bendamustine represents an important new advance for patients who have follicular lymphoma that has relapsed after, or was refractory to a rituximab-based treatment regimen."

About the Health Canada Approval of GAZYVA
Health Canada's approval of GAZYVA is based on data from the pivotal Phase III GADOLIN study, which was an open-label, multicenter, randomized, two-arm study enrolling 396 patients, 24 per cent of who (n=99) were Canadian patients enrolled at 10 clinical trials sites across the country. Data from the GADOLIN study demonstrates that treatment with GAZYVA plus bendamustine results in progression-free survival (PFS) for a median of 29.2 months compared to bendamustine alone with a median of 13.7 months based on investigator-assessed PFS.6

"While many Canadians live with follicular lymphoma for several years, there are limited options available today that address the needs of patients who do not respond to their prescribed treatment or their current treatment stops working," said Robin Markowitz, CEO of Lymphoma Canada. "It is exciting to see that research is continuing to drive advances in this space, providing patients with more treatment options to help them combat their disease."  

About Follicular Lymphoma
Follicular lymphoma is a form of blood cancer that develops from B-lymphocytes (B-cells). In healthy immune systems, B-cells produce antibodies to help fight off infections. However, in lymphomas, B-cells grow uncontrollably and spread to different organs, including the spleen, lymph nodes and bone marrow.7

The average age of diagnosis is 59 years of age and the condition is slightly more common in women than in men.8

About the GADOLIN Study
GADOLIN is a Phase III open-label, multicenter, randomized, two-arm study evaluating GAZYVA plus bendamustine followed by GAZYVA alone until disease progression or for up to two years compared to bendamustine alone.9

GADOLIN included 396 patients with indolent non-Hodgkin's lymphoma (NHL), including 321 patients with follicular lymphoma, whose disease progressed during or within six months of prior RITUXAN-based therapy.10 The primary endpoint of the study was progression-free survival (PFS) assessed by an independent review committee.11 Secondary endpoints included PFS as assessed by investigator review, best overall response, complete response, partial response, duration of response, overall survival and safety profile.12

Results in follicular lymphoma showed the GAZYVA regimen resulted in a 52 per cent reduction in the risk of disease worsening or death, compared to bendamustine alone.13 The most frequently observed serious adverse events (≥ two per cent) that occurred in patients treated with GAZYVA plus bendamustine were febrile neutropenia, neutropenia, sepsis, infusion related reactions, pyrexia, pneumonia and thrombocytopenia.14

About GAZYVA® (obinutuzumab)
GAZYVA is an engineered 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.15

GAZYVA is currently approved for use in combination with chlorambucil in more than 70 countries — including Canada — to treat people with previously untreated chronic lymphocytic leukemia.

GAZYVA was studied in a global Phase III open-label, multicenter, randomized, two-arm study called GALLIUM to examine the efficacy and safety of the medicine plus chemotherapy, as compared to RITUXAN plus chemotherapy, followed by GAZYVA or RITUXAN alone for up to two years. It included 1,401 patients with previously untreated indolent non-Hodgkin lymphoma.16

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims for improving patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. 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.

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.

All trademarks used or mentioned in this release are protected by law.

References
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1 GAZYVA Product Monograph, December 29, 2016.
2 Canadian Cancer Society Statistics 2016. Special Topic: HPV Associated Cancers. Canadian Cancer Society. 2016. http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2016-EN.pdf?la=en. Accessed November 28, 2016. 
3 Kuruvilla, J, Assouline, S, Hodgson, D, MacDonald, D, Stewart, D, Christofides, A, Komolova, M and Connors, J. A Canadian evidence-based guideline for the first-line treatment of follicular lymphoma: joint consensus of the lymphoma Canada scientific advisory board. https://www.lymphoma.ca/sites/default/files/images/canadian_first-line_fl_guidelines_for_educational_use_jan._2015.pdf. Accessed November 28, 2016.
4 Dotan, Efrat, Aggarwal, Charu, Smith, Mitchell R. Impact of Rituximab (Rituxan) on the Treatment of B Cell Non-Hodgkin's Lymphoma. 2010 Mar; 35(3): 148-157. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2844047/. Accessed December 22, 2016.
5 Sousou, Tarek and Friedberg, Jonathan. Rituximab in Indolent Lymphomas. Semin Hematol. 2010 Apr; 47(2): 133–142. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2848176/. Accessed November 30, 2016.
6 Sehn L, Chua NS et al. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Accessed November 30, 2016.
7 The First-Line Treatment of Follicular Lymphoma in Canada. Lymphoma Canada. https://www.lymphoma.ca/sites/default/files/images/fl_patient-guide-booklet-english.pdf Accessed December 7, 2016
8 Non-Hodgkin lymphoma. Canadian Cancer Society 2016. https://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/follicular-lymphoma/?region=on Accessed on December 9, 2016.
9 Sehn L, Chua NS et al. GADOLIN: Primary results from a phase III study of obinutuzumab plus bendamustine compared with bendamustine alone in patients with rituximab-refractory indolent non-Hodgkin lymphoma. ASCO 2015 Chicago Abstract LBA8502. http://meetinglibrary.asco.org/content/147837-156. Accessed November 30, 2016.
10 Sehn L, Chua NS et al. GADOLIN: Primary results from a phase III study of obinutuzumab plus bendamustine compared with bendamustine alone in patients with rituximab-refractory indolent non-Hodgkin lymphoma. ASCO 2015 Chicago Abstract LBA8502. http://meetinglibrary.asco.org/content/147837-156. Accessed November 30, 2016.
11 Sehn L, Chua NS et al. GADOLIN: Primary results from a phase III study of obinutuzumab plus bendamustine compared with bendamustine alone in patients with rituximab-refractory indolent non-Hodgkin lymphoma. ASCO 2015 Chicago Abstract LBA8502. http://meetinglibrary.asco.org/content/147837-156. Accessed November 30, 2016.
12 Sehn L, Chua NS et al. GADOLIN: Primary results from a phase III study of obinutuzumab plus bendamustine compared with bendamustine alone in patients with rituximab-refractory indolent non-Hodgkin lymphoma. ASCO 2015 Chicago Abstract LBA8502. http://meetinglibrary.asco.org/content/147837-156. Accessed November 30, 2016.
13 Sehn L, Chua NS et al. GADOLIN: Primary results from a phase III study of obinutuzumab plus bendamustine compared with bendamustine alone in patients with rituximab-refractory indolent non-Hodgkin lymphoma. ASCO 2015 Chicago Abstract LBA8502. http://meetinglibrary.asco.org/content/147837-156. Accessed November 30, 2016.
14 GAZYVA Product Monograph, December 29, 2016.
15 GAZYVA Product Monograph, November 25, 2014.
16 Marcus, Robert E., Davies, Andrew J., Ando, Kiyoshi. Obinutuzumab-Based Induction and Maintenance Prolongs Progression-Free Survival (PFS) in Patients with Previously Untreated Follicular Lymphoma: Primary Results of the Randomized Phase 3 GALLIUM Study. 2016. 128:6. http://www.bloodjournal.org/content/128/22/6?sso-checked=true. Accessed December 23, 2016.

SOURCE Roche Canada

For further information: Claire Cockburn, Roche Canada, 905-542-4648, claire.cockburn@roche.com; Jillian Pastirik, Edelman Public Relations, 416-849-1518, jillian.pastirik@edelman.com


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