Celgene International has obtained FDA priority review status for Abraxane (paclitaxel protein-bound particles for injectable suspension) supplemental new drug application (sNDA).
The application covers the use of Abraxane and gemcitabine combination therapy for the front line treatment of patients with advanced pancreatic cancer.
In April 2013, the European Medicines Agency also accepted Marketing Authorization Application for Abraxane, in combination with gemcitabine, for the first-line treatment of advanced pancreatic cancer patients.
Data from an open-label, phase III, randomized study, Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT), conducted in 861 patients with metastatic pancreatic cancer was included in both the applications.
Dossiers for registration in other countries/regions are expected to be submitted later this year.
