Celgene has today announced that Revlimid has approved for the treatment of follicular lymphoma and marginal zone lymphoma in the combination of rituximab following priority review designation.
This combination is the first chemotherapy-free combination indicated for the treatment of follicular lymphoma and marginal zone lymphoma who did not respond to the previous treatment.
The approval is based on the Phase 3 AUGMENT study comparing the combination of Revlimid and rituximab in combination with placebo and rituximab combination. The primary endpoint is progression-free survival. PFS was 39.4 months for patients treated with Revlimid and rituximab combination versus 14.1 months treated with rituximab and placebo. Overall survival is 16 in Revlimid + rituximab vs. 26 deaths in placebo +rituximab.
The approval is under consideration by the European Medicines Agency in Europe.