The Food and Drug Administration has approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).
Approval is based on a 28% lower risk of disease progression or death after 2 years for patients on the obinutuzumab-based regimen, compared with patients who received a rituximab-based regimen in the phase 3 GALLIUM study (hazard ratio, 0.72; 95% confidence interval, 0.56-0.93; P = .0118). GALLIUM included 1,385 patients with previously untreated non-Hodgkin lymphoma, of whom 1,202 patients had advanced follicular lymphoma (stage II bulky, III, or IV), the company said in a press release.
The most common adverse events associated with obinutuzumab were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea. The most common significant adverse events are low white blood cell count, low white blood cell count with fever, and low platelet count.
“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,” said Sarah Horning, MD, chief medical officer and head of global product development at Genentech, in the company press release.