Celgene Advances ABRAXANE® (nab-paclitaxel) Development in Difficult-to-Treat Cancers

Celgene International Sàrl, a subsidiary of Celgene Corporation

today announced a series of milestones related to the development of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in metastatic pancreatic cancer, advanced non-small cell lung cancer, metastatic breast cancer and metastatic melanoma. The company completed enrollment in the largest phase III study of metastatic pancreatic cancer to date (NCI clinical trial reference number NCT00844649). In this global study, 861 patients were randomized to receive either nab-paclitaxel plus gemcitabine or gemcitabine alone. Results from the study with a primary endpoint of overall survival are expected during the second half of 2012. The design of the study is based on the promising results of a phase I/II study in 67 patients published in the Journal of Clinical Oncology in December 2011 (Von Hoff et al, 2011 JCO). In advanced non-small cell lung cancer, additional regulatory submissions were filed in Japan, Australia and New Zealand, which were based on the positive randomized phase III study reported online in the Journal of Clinical Oncology (Socinski et al, 2012 JCO (epub)). In the United States, the Food and Drug Administration (FDA) has set a PDUFA date of Oct. 12, 2012.