24 May 2013 - 24 May 2013 - US Celgene Corp (NASDAQ:CELG) said on Thursday that its supplemental New Drug Application (sNDA) for ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in advanced pancreatic cancer has obtained US FDA Priority Review status.

The application is for the use of ABRAXANE in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.

The Prescription Drug User Fee Act (PDUFA) action date for the application is set for 21 September, the company said further.

Last month, the European Medicines Agency (EMA) also accepted for review a Type II Variation to the current marketing application (MAA) for ABRAXANE, in combination with gemcitabine, for the first-line treatment of patients with advanced pancreatic cancer. Celgene said it intends to file dossiers for registration in other countries during the current year.

The company added that it plans to commence a Phase III multi-centre, randomised, controlled study of ABRAXANE plus gemcitabine in the adjuvant pancreatic cancer setting.