Health Canada Approves GAZYVA® for Previously Untreated Advanced Follicular Lymphoma
GAZYVA is the first anti-CD20 treatment in 15 years for the most common subtype of indolent lymphoma.1
MISSISSAUGA, ON, July 9, 2018 /CNW/ -- Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved GAZYVA® (obinutuzumab), in combination with chemotherapy, followed by GAZYVA monotherapy in patients achieving a response, for the treatment of patients with previously untreated stage II bulky (>7cm), III or IV follicular lymphoma (FL).2
The GALLIUM clinical study demonstrated the risk of progression or death was significantly reduced in patients who received a GAZYVA-based regimen compared to those who received a RITUXAN® (rituximab)-based regimen, as an initial (first-line) therapy.3
"Follicular lymphoma typically becomes harder to treat each time it returns, making Gazyva an important advancement for patients," says Dr. Richard Van der Jagt, a clinical hematologist at The Ottawa Hospital and associate professor at the University of Ottawa. "The approval of Gazyva is encouraging for Canadians living with this form of blood cancer, as the treatment has shown to significantly delay disease progression over Rituxan, which has been the standard of care for more than a decade."
In 2016, an estimated 2,900 Canadians were diagnosed with FL,4 an incurable form of indolent (slow-growing) non-Hodgkin's lymphoma (NHL).5 This form of NHL usually occurs in people 50 years of age or older and is slightly more common in women than in men.6 People diagnosed with FL usually have tumours in many parts of the body at the time of diagnosis and it can often develop into more aggressive forms of NHL.7
"After being part of the clinical trial, I'm excited to hear about the approval of Gazyva for the thousands of other Canadians living with follicular lymphoma," says Anne, an Ottawa resident who was diagnosed with FL in 2012 and participated in the GALLIUM trial. "I'm happy to be living in remission thanks to this new treatment option, so that I can enjoy time with my husband and children."
About the Health Canada Approval
The Health Canada approval of GAZYVA is based on data from the multicentre phase III, open label, randomized GALLIUM trial studying 1,202 patients, with 138 Canadian patients enrolled at seven clinical trial sites across Canada. Patients with previously untreated stage II (bulky)/III/IV FL were randomized 1:1 to receive either GAZVYA or rituximab in combination with chemotherapy (CHOP, CVP, or bendamustine) followed by GAZYVA or rituximab monotherapy in patients who achieved a complete or partial response. Patients were stratified by chemotherapy (selected by each investigational site; all patients at that site received the chosen chemotherapy regimen for the duration of the study), follicular lymphoma international prognostic index (FLIPI) risk group, and geographic region. The study excluded patients with FL grade 3b or transformed disease.8 Data from the study demonstrated the following:
- 83.4 per cent of patients in the GAZYVA-based regimen and 78.9 per cent of patients in the rituximab-based regimen were progression-free at 3 years.
- A 28 per cent complete response (CR) rate at the end of induction therapy determined by CT in the GAZYVA-based regimen in comparison to 27 per cent in the rituximab-based regimen.
- A 91 per cent overall response (OR) rate determined by CT in the GAZYVA-based regimen in comparison to 88 per cent in the rituximab-based regimen.9
During the monotherapy period with GAZYVA, the most common adverse events in patients with previously untreated iNHL were cough, neutropenia, upper respiratory tract infection, viral upper respiratory tract infection, diarrhea, arthralgia, fatigue, sinusitis, infusion reactions, pneumonia, herpes zoster, lower respiratory tract infection, pyrexia, back pain, headache, urinary tract infection, nausea, bronchitis, and vomiting. The most common Grade 3-4 adverse events during the monotherapy period were neutropenia, pneumonia (with 2 deaths due to pneumonia reported in the GAZYVA treated arm), and febrile neutropenia.10
In the study, 72 per cent of patients in the GAZYVA-based regimen experienced an infusion reaction (all grades). The incidence of Grade 3-4 infusion reactions for these patients was 12 per cent. In Cycle 1, the incidence of infusion reactions (all grades) was 62 per cent in the GAZYVA treated arm with Grade 3-4 infusion reactions reported in 10 per cent. The incidence of infusion reactions (all grades) was highest on Day 1 (60 per cent), and decreased on Days 8 and 15 (9 per cent and 6 per cent, respectively). During Cycle 2, the incidence of infusion reactions (all grades) in the GAZYVA treated arm was 13 per cent and decreased with subsequent cycles. During GAZYVA monotherapy treatment, infusion reactions (all grades) were observed in 9 per cent of patients. Overall, 2 per cent of patients in the GALLIUM study experienced an infusion reaction leading to discontinuation of GAZYVA.11
About Follicular Lymphoma
Follicular lymphoma (FL) is a type of non-Hodgkin's lymphoma (NHL)12 and is an incurable indolent (slow-growing) form of the disease that develops when the body makes abnormal B-lymphocytes (white blood cells that fight infection).13,14 It is the most common subtype of indolent lymphoma.15 FL is slightly more common in women than in men and is typically seen in people ages 50 or older.16
About GAZYVA® (obinutuzumab)
GAZYVA is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It attacks targeted cells both directly and together with the body's immune system.17
It is approved by Health Canada to treat patients with previously untreated chronic lymphocytic leukemia (CLL), for adults with previously untreated FL and for patients who relapsed after treatment, or are refractory to, a RITUXAN-based regimen.18
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(1) Marcus, R., et al. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. The New England Journal of Medicine. October 5, 2017. (2) GAZYVA Product Monograph, July 2018. (3) Marcus, R., et al. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. The New England Journal of Medicine. October 5, 2017. 4 Leukemia & Lymphoma Society of Canada. About Blood Cancer. http://www.llscanada.org/disease-information/facts-and-statistics. Accessed June 18. 5 Kuruvilla, J., et al. 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 June 11, 2018. 6 Canadian Cancer Society. Non-Hodgkin Lymphoma. https://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/follicular-lymphoma/?region=on. Accessed May 28, 2018. 7 Lymphoma Canada. NHL Subtypes. https://www.lymphoma.ca/lymphoma/non-hodgkin-lymphoma/nhl-subtypes#2. Accessed June 12, 2018. 8 GAZYVA Product Monograph. July 2018. 9 GAZYVA Product Monograph. July 2018. 10 GAZYVA Product Monograph, July 2018. 11 GAZYVA Product Monograph, July 2018. 12 Lymphoma Canada. NHL Subtypes. https://www.lymphoma.ca/lymphoma/non-hodgkin-lymphoma/nhl-subtypes#2. Accessed June 12, 2018. 13 Kuruvilla, J., et al. 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 June 11, 2018. 14 Leukemia & Lymphoma Society of Canada. Non-Hodgkin's Lymphoma. http://www.llscanada.org/sites/default/files/National/CANADA/Pdf/InfoBooklets/Non-Hodgkin%20Lymphoma.pdf. Accessed May 22, 2018. 15 Lymphoma Canada. NHL Subtypes. https://www.lymphoma.ca/lymphoma/non-hodgkin-lymphoma/nhl-subtypes#2. Accessed June 12, 2018. 16 Canadian Cancer Society. Non-Hodgkin Lymphoma. https://www.cancer.ca/en/cancer-information/cancer-type/non-hodgkin-lymphoma/non-hodgkin-lymphoma/follicular-lymphoma/?region=on. Accessed May 28, 2018. 17 GAZYVA Product Monograph, July 2018. 18 GAZYVA Product Monograph, July 2018.
SOURCE Roche Canada