Celgene International Sarl, a subsidiary of Celgene Corp. (CELG: Quote), Sunday revealed data from multiple presentations evaluating Abraxane in combination with carboplatin in patients with advanced non-small cell lung cancer.
The two reports presented data from retrospective analyses of CA-031, the phase III, multi-center, randomized study where patients received either nab-paclitaxel weekly plus carboplatin every three weeks or paclitaxel every three weeks plus carboplatin 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 (Prescription Drug User Fee Act) date for the submission is October 12, 2012.
Results of the study published on April 30, 2012 in the Journal of Clinical Oncology demonstrated a higher overall response rate, the approved primary end-point of the study based on a Special Protocol Assessment, for patients in the nab-paclitaxel arm compared to those in the paclitaxel arm.
The first sub-analysis evaluated elderly patients in the study and patients under 70. In both groups, overall response rate was higher in patients receiving nab-paclitaxel, though the difference was not significant in elderly patients between the arms of the study.
The second report evaluated patients with squamous-cell histology and non-squamous cell patients. The nab-paclitaxel arm demonstrated a significantly higher overall response rate and a slight improvement in overall survival, compared to the paclitaxel arm.
These results are from an investigational study and Abraxane is not indicated in the treatment of non-small cell lung cancer.
CELG traded on Friday at $65.33, down $2.92 or 4.28%, on a volume of 4.5 million shares on the Nasdaq.
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by RTT Staff Writer
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