On 26 February 2019, the US Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) and granted priority review to the lenalidomide and rituximab (R2) regimen, for the treatment of patients with previously treated relapsed/refractory (R/R) follicular lymphoma (FL) and marginal zone lymphoma (MZL).
The sNDA for the R2 regimen was based on the results from the multicenter, randomized, double-blind, phase III AUGMENT (NCT01938001) trial, which assessed the efficacy of the R2 regimen compared to single-agent rituximab therapy in patients with R/R FL or MZL. The results from this trial showed that according to independent review committee, progression-free survival in patients in the R2 arm was 39.4 months (95% CI, 22.9–not evaluable) compared to 14.1 months (95% CI, 11.4–16.7) in patients receiving rituximab monotherapy, with a median follow-up of 28.3 months. Further results from the AUGMENT study were presented at the 60th Annual Meeting of the American Society of Hematology (ASH), read more here.
According to the drug manufacturers, the R2 regimen “has the potential to offer patients with previously treated follicular lymphoma and marginal zone lymphoma a chemotherapy-free option”.