Celgene’s sNDA for Revlimid Gets Priority Review

Celgene Corp.’s sNDA for Revlimid, for the treatment of relapsed or refractory multiple myeloma, has been granted a Priority Review designation by the FDA. The company is seeking approval to market Revlimid in combination with dexamethasone as a proposed indication for the treatment of multiple myeloma patients who have received at least one prior therapy. Priority Review is granted to products that, if approved, would be a significant improvement compared to existing marketed products or therapies in the treatment, diagnosis, or prevention of a disease.

The sNDA submission is based on the safety and efficacy results of two large randomized Phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating Revlimid plus dexamethasone in multiple myeloma patients that have received at least one prior therapy. Based on a pre-specified interim analysis, both studies achieved the primary endpoint of time to disease progression (TTP) with combination therapy of lenalidomide and dexamethasone over that of placebo and dexamethasone.