FDA Approves New Treatment Option for Previously Untreated Advanced Follicular Lymphoma
November 16th, 2017
On November 16, 2017, the FDA approved Gazyva® (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
News in brief
- The approval is based on results from the Phase III GALLIUM study, which showed superior progression-free survival (PFS) for patients who received this Gazyva-based regimen compared with those who received a Rituxan® (rituximab)-based regimen as an initial (first-line) therapy.
- Follicular lymphoma, the most common slow-growing (indolent) form of non-Hodgkin’s lymphoma (NHL), is incurable and becomes harder to treat each time it returns.
- This Gazyva regimen is the first treatment option to demonstrate superior PFS over Rituxan-based therapy for people with previously untreated advanced follicular lymphoma.
- With this approval, Gazyva is available in the United States for three different indications across two common types of blood cancer.
"Today’s Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma who hope to delay disease progression for as long as possible. We’re pleased we can now offer patients with this incurable blood cancer an initial treatment option shown to improve upon Rituxan, the standard of care in this setting for more than 10 years.”