Celgene Corp.'s (CELG: Quote) unit, Celgene International Sàrl, reported phase III study data MM-003 of pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone in patients with refractory multiple myeloma who have failed therapy with both bortezomib and lenalidomide, administered either alone or in combination. MM-003 met the primary endpoint of improvement in progression-free survival or PFS.
PFS was significantly longer in patients who received pomalidomide plus low-dose dexamethasone compared with those who received high-dose dexamethasone.
According to the study design, an interim analysis of overall survival was conducted. During this analysis, pomalidomide plus low-dose dexamethasone demonstrated a highly statistically significant improvement in overall survival that crossed the upper boundary for superiority. Consequently, the Data Monitoring Committee urged that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed over to pomalidomide plus low-dose dexamethasone.
A Marketing Authorisation Application for pomalidomide combined with low-dose dexamethasone was submitted to the EMA in May 2012, and Celgene expects a decision by European regulatory authorities in the second half of 2013. Further, a new drug application has been accepted for review by the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act date of Feb. 10, 2013.
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by RTT Staff Writer
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