The U.S. Food and Drug Administration (FDA) has approved obinutuzumab in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who have relapsed after or are refractory to a rituximab-containing regimen.
Obinutuzumab was approved under the FDA’s Priority Review program. This is the second approval for obinutuzumab. Previously, it was approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.
This new approval was based on results from the phase III, randomized, open-label, multicenter GADOLIN trial of 321 patients with FL who received either obinutuzumab plus bendamustine (n=155) or bendamustine (n=166).
Patients treated with obinutuzumab experienced longer progression-free survival than those treated with bendamustine alone (PFS; median PFS = not reached vs. 13.8 months, respectively; hazard ratio = 0.48 [95% CI 0.34-0.68]; p<0.0001).
In the safety analysis, the most common adverse events (reported in ≥10% of patients) in the obinutuzumab population were infusion-related reactions, neutropenia, nausea, fatigue, cough, diarrhea, constipation, pyrexia, thrombocytopenia, vomiting, upper respiratory tract infection, decreased appetite, arthralgia, sinusitis, anemia, asthenia and urinary tract infection. Serious adverse events were reported in 38 percent of obinutuzumab-treated patients. The most common serious adverse events (reported in more than 2% of patients) were febrile neutropenia, neutropenia, infusion-related reactions, sepsis, pneumonia, and pyrexia.
Source: U.S. FDA press release, February 26, 2016.