FDA approves Abraxane for pancreatic cancer

FDA approved an sNDA from Celgene Corp. (NASDAQ:CELG) 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). The CVR, which trades on NASDAQ under the ticker CELGZ, was up $1.28 (17%) to $8.80 on Friday. Celgene acquired Abraxis in 2010 for about $2.9 billion plus the CVR.

Abraxane is under review for pancreatic cancer in the EU. The albumin stabilized nanoparticle formulation of paclitaxel is approved in the U.S. for first-line treatment of advanced non-small cell lung cancer (NSCLC), and in the U.S., EU and at least 12 other countries as second-line treatment of metastatic breast cancer (see BioCentury Extra, May 23). ...