FDA Grants Lenalidomide/Rituximab Priority Review for Indolent Non-Hodgkin Lymphoma

February 26, 2019 – The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the R2 regimen of lenalidomide plus rituximab for use in patients with previously treated follicular lymphoma and marginal zone lymphoma (MZL). The sNDA is based on the phase III AUGMENT trial, in which the R2 regimen reduced the risk of disease progression or death by 54% versus rituximab alone in patients with relapsed/refractory … (leggi tutto)