Abraxane nab-paclitaxel regulatory update

FDA accepted and granted Priority Review to an sNDA from Celgene seeking to expand the label of Abraxane nab-paclitaxel to include first-line treatment of advanced pancreatic cancer in combination with gemcitabine. The PDUFA date is Sept. 21. Celgene also said EMA accepted for review in April a Type II variation application to expand the European label for the albumin stabilized nanoparticle formulation of paclitaxel to include the indication. Both applications include data from the Phase III MPACT trial (see BioCentury, Jan. 28). Celgene said it plans to submit regulatory applications in additional countries this year. ...