Product and Pipeline Updates
REVLIMID: The Company presented final data from a pivotal phase II trial in relapsed/refractory mantle cell lymphoma at the American Society of Hematology (ASH) meeting in December 2012. The trial achieved its primary efficacy endpoints as specified in Special Protocol Assessment (SPA) requirements. A Supplemental New Drug Application (sNDA) was submitted to the FDA and a decision is expected in 2013.
Also at ASH 2012, there was an update of the MM-015 trial. Mature survival data from the MM-015 trial are expected in first quarter 2013 allowing for a resubmission of the marketing application for REVLIMID in newly diagnosed multiple myeloma (NDMM) with the European Medicines Agency (EMA) in the second half 2013.The Company presented data on a phase II trial of the combination of REVLIMID with RITUXAN in patients with Non-Hodgkin’s Lymphoma (NHL) at ASH 2012. Enrollment in phase III trials in both NHL and chronic lymphocytic myeloma (CLL) are ongoing with enrollment in the phase III CLL-008 trial due to complete in the first quarter 2013. POMALYST: The Company presented final phase III data from MM-003 in relapsed and refractory multiple myeloma at ASH 2012 showing a statistically significant overall survival benefit of POMALYST in combination with low-dose dexamethasone versus high-dose dexamethasone. The data supports the pending application for relapsed refractory multiple myeloma (RRMM) with the EMA. An EMA decision is expected in 2013. In the U.S., an action by the FDA is expected by the February 10, 2013 Prescription Drug User Fee Act (PDUFA) date. Oncology ABRAXANE: The Company reported that the ABRAXANE phase III trial of over 840 patients with pancreatic cancer met the primary endpoint of overall survival. ABRAXANE in combination with gemcitabine demonstrated a statistically significant improvement in overall survival of 8.5 months compared to 6.7 months in patients receiving gemcitabine alone (HR 0.72, P=0.000015). Based on the results of this trial, Celgene plans to submit dossiers for registration in the U.S. and Europe during the first half 2013 followed by submissions in other countries/regions during the second half 2013.