Celgene Corp.'s (CELG) 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.
For comments and feedback contact: editorial@rttnews.com
Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.