ABRAXANE received FDA approval for the first-line treatment of patients with advanced NSCLC in October, 2012. Through regional partnerships, Celgene has NSCLC applications under review in Japan, Australia, and New Zealand and anticipates receiving Regulatory Health Authority decisions in first half 2013. In addition, Celgene is evaluating regulatory strategies to obtain NSCLC in other countries.Positive data from the phase III trial comparing ABRAXANE to dacarbazine in over 510 treatment-naïve metastatic malignant melanoma patients were presented at the Society of Melanoma Research meeting November, 2012. In this trial, chemotherapy-naïve patients with metastatic melanoma treated with ABRAXANE had a progression free survival of 4.8 months versus 2.5 months in patients treated with dacarabzine (HR:0.792; 95.1% CI: 0.631, 0.992; P=0.044). Mature phase III overall survival data are expected in mid-2013.
Celgene Reports Strong Fourth Quarter And Full Year 2012 Operating And Financial Results
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