Health Canada has approved Gazyva (obinutuzumab) to treat patients with follicular lymphoma.
Follicular lymphoma is a slow growing form of non-Hodgkin’s lymphoma (NHL) in which patients produce abnormal B-lymphocytes (white blood cells that fight infection).
According to Lymphoma Canada, current treatment options for follicular lymphoma are dependent on the patient’s health and stage of cancer but may include chemotherapy (e.g., CHOP) and/or immunotherapy [Rituxan (rituximab)]. Like Rituxan, Gazyva is an anti-CD20 monoclonal antibody but the latter drug is more effective. In a news release, Richard Van der Jagt, MD, clinical hematologist at The Ottawa Hospital said, “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.”
More specifically, Gazyva is approved in combination with chemotherapy, followed by Gazyva monotherapy, for treating patients with untreated stage II bulky (>7cm), III or IV follicular lymphoma.
The approval was largely based on the phase 3 GALLIUM study that was published last year in the New England Journal of Medicine in which 1202 patients were randomized to receive Gazyva or Rituxan in combination with chemotherapy (CHOP, CVP, or bendamustine) followed by Gazyva or Rituxan monotherapy in patients who achieved a complete or partial response.
The study observed that patients in the Gazyva-treated group has significantly better results with regard to progressive-free survival, relapse, and death, compared to those treated with Rituxan.
The most common Grade 3–4 adverse events observed with Gazyva monotherapy were neutropenia, pneumonia, and febrile neutropenia.
Infusion reactions were also commonly observed with Gazyva (occurring in 72% of patients) but only led to discontinuation of treatment in 2% of the patients.
For more information about follicular lymphoma, visit www.lymphoma.ca