FDA grants priority review for Revlimid + rituximab for treatment of previously treated follicular and marginal zone lymphoma.- Celgene
Celgene Corporation announced that the FDA has granted Priority Review designation for the company�s supplemental New Drug Application (sNDA) for Revlimid (lenalidomide) in combination with rituximab (R�) for the treatment of patients with previously treated follicular and marginal zone lymphoma. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set its action date as 27 June 2019.
The sNDA is based on results from the randomized, double-blind, phase III AUGMENT study, which evaluated the efficacy and safety of the investigational R� combination versus rituximab plus placebo in patients with relapsed/refractory follicular and marginal zone lymphoma. Results from the study were presented at the 2018 American Society of Hematology (ASH) Annual Meeting and Exposition.
Earlier this year, Celgene submitted and had accepted a Marketing Authorization Application (MAA) for R2 to the European Medicines Agency (EMA) for the treatment of relapsed/refractory follicular and marginal zone lymphoma.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.