During the first half of 2013, we expect a decision by the Committee for Medicinal Products for Human Use (CHMP) on REVLIMID for MDS deletion 5q and to complete enrollment in the phase III ORIGIN (CLL-008) trial in chronic lymphocytic leukemia.Pomalidomide: The international phase III trial (MM-003) comparing pomalidomide with low-dose dexamethasone to high-dose dexamethasone in relapsed refractory multiple myeloma patients recently achieved the primary endpoint of progression-free survival, in addition to the key secondary endpoint of overall survival. The Phase I/II dose-ranging trial (MM-005) evaluating the combination of pomalidomide, dexamethasone and bortezomib continues with data expected at this year’s ASH meeting. The regulatory reviews of pomalidomide for relapsed refractory multiple myeloma are progressing with an FDA decision expected in February 2013 and a CHMP decision expected during the second half of 2013.
Celgene Reports Third Quarter 2012 Operating And Financial Results
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