Positive data from Phase III study of Abraxane (Celgene Oncology) for NSCLC patients

A retrospective analyses of CA-031, the Phase III study where Non-Small Cell Lung Cancer patients received either Abraxane (nab-paclitaxel), from Celgene Oncology, plus carboplatin or paclitaxel plus carboplatin demonstrated a higher overall response rate for patients in the Abraxane arm compared to those in the paclitaxel arm (33% vs. 25%). A second analysis evaluating patients with squamous-cell histology and non-squamous cell patients shows that in the former group, the Abraxane arm demonstrated a significantly higher overall response rate (41% vs. 24%), similar PFS (5.6 vs. 5.7 months) and a slight improvement in overall survival (10.7 vs. 9.5 months), compared to the paclitaxel arm. Based on the data from CA-031, Celgene submitted an sNDA for Abraxane for the first-line treatment of patients with advanced NSCLC with the FDA in December 2011. The current PDUFA date for the submission is Oct. 12, 2012. The data was presented at the American Society of Clinical Oncology meeting.