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news.The FDA has granted Celgene Corporation a priority review designation for its supplemental new drug application for Revlimid for the treatment of relapsed or refractory multiple myeloma.
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The company is seeking approval to market Revlimid in combination with dexamethasone in a proposed indication for the treatment of multiple myeloma patients who have received at least one prior therapy subject to FDA review and approval.
Priority review is granted to a pharmaceutical product that, if approved, would be a significant improvement compared to existing marketed products or approved therapies in the treatment, diagnosis, or prevention of a disease.
The supplemental new drug application (sNDA) submission is based upon the safety and efficacy results of two large randomized pivotal phase III special protocol assessment trials 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 with combination therapy of lenalidomide and dexamethasone over that of placebo and dexamethasone.
Revlimid is approved by the FDA for treatment of patients with transfusion-dependent anemia due to low or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.