Health Canada’s decision follows Gazyva’s approval in the U.S. and Europe for a similar indication. It was based on data from the GALLIUM Phase 3 clinical trial (NCT01332968), which showed that Gazyva was better than Rituxan (rituximab) at extending the time a person lives without signs of disease worsening.
“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,” Richard Van der Jagt, MD, said in a press release. Van der Jagt is a clinical hematologist at The Ottawa Hospital and associate professor at the University of Ottawa.
“Follicular lymphoma typically becomes harder to treat each time it returns, making Gazyva an important advancement for patients,” he said.
The GALLIUM study enrolled 1,202 patients with advanced follicular lymphoma, including 138 patients from Canada. Participants were randomized to receive intravenous infusions of Gazyva or Rituxan plus chemotherapy for 6-8 cycles.
Chemotherapy regimens included: cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP); cyclophosphamide, vincristine, and prednisone (CVP); or bendamustine.
If a partial or complete response was obtained at the end of this induction therapy, patients continued receiving the same antibody as a maintenance therapy. This was given for an additional two years, or until disease progression, relapse, or death.
Gavyva was better at delaying disease progression, with 83.4% of patients being progression-free at three years, compared to 78.9 of those receiving Rituxan.
Overall, this translated to a 32% reduction in the risk of disease progression or death. However, patients receiving bendamustine benefitted the most, with a 37% risk reduction.
The rate of responses and complete responses also were slightly better in the Gazyva group, researchers found.
The latest results from GALLIUM were presented in June at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting, in the poster “Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety.”
“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,” said Anne, an Ottawa resident who was diagnosed with follicular lymphoma in 2012 and was one of the participants of the GALLIUM study. “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.”
Gazyva also is approved in Canada for the treatment of chronic lymphocytic leukemia and for patients with relapsed or refractory follicular lymphoma, who failed prior therapy with Rituxan.