The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the R2
regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) for use in patients with previously treated follicular lymphoma and marginal zone lymphoma (MZL).
The double-blind, phase III AUGMENT trial included 358 patients with relapsed/refractory follicular lymphoma or MZL in need of treatment. Across the study, 295 patients had follicular lymphoma and 63 patients had MZL. Patient had to have received at least 1 prior chemotherapy, immunotherapy, or chemoimmunotherapy regimen, and could not be rituximab refractory.
Patients were randomized to rituximab at 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 through 5, plus either 20 mg of lenalidomide/daily on days 1 through 21 every 28 days for up to 12 cycles (n = 178) or placebo (n = 180).
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