BioCentury
ARTICLE | Clinical News

Abraxane nab-paclitaxel regulatory update

September 9, 2013 7:00 AM UTC

FDA approved an sNDA from Celgene to expand the label of Abraxane nab-paclitaxel to include first-line treatment of advanced pancreatic cancer in combination with gemcitabine. The label includes a claim of overall survival (OS) benefit for pancreatic cancer, triggering a $300 million milestone payment to holders of the Abraxis BioScience Inc. contingent value right (CVR). Celgene acquired Abraxis in 2010 for about $2.9 billion plus the CVR (see BioCentury, July 5, 2010). ...