Posted by Michael Wonder on 29 May 2019
FDA approves Revlimid (lenalidomide) in combination with rituximab for the treatment of adult patients with previously treated follicular lymphoma or marginal zone lymphoma
28 May 2019 - Approval marks the first chemotherapy-free combination regimen for patients who have relapsed or did not respond to previous treatment.
Celgene Corporation today announced the U.S. FDA approved Revlimid (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. This is the first FDA approved combination treatment regimen for patients with these indolent forms of non-Hodgkin’s lymphoma that does not include chemotherapy.
The approval of R2 is based primarily on results from the randomised, double-blind, Phase 3 AUGMENT study, which evaluated the efficacy and safety of the R² combination versus rituximab plus placebo in patients with previously treated FL (n=295) and MZL (n=63).
