Multiple Analyses Evaluating Celgene's ABRAXANE in Non-Small Cell Lung Cancer Presented at ASCO
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) announced Saturday results from multiple presentations evaluating ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with carboplatin in patients with advanced non-small cell lung cancer during the 48th American Society of Clinical Oncology Annual Meeting in Chicago, IL.
The two reports presented data from retrospective analyses of CA-031, the phase III, multi-center, randomized study where patients received either nab-paclitaxel (100mg/m2) weekly plus carboplatin (AUC=6) every three weeks (n=521) or paclitaxel (200mg/m2) every three weeks plus carboplatin (AUC=6) (n=531) as first-line therapy for advanced non-small cell lung cancer.
Based on the data from CA-031, Celgene submitted an sNDA for ABRAXANE for the first-line treatment of patients with advanced non-small cell lung cancer with the U.S. Food and Drug Administration in December 2011. The current PDUFA date for the submission is Oct. 12, 2012.
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