Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, has received the Priority Review designation from US Food and Drug Administration (FDA) to supplemental New Drug Application (sNDA) for the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first - line treatment of patients with advanced pancreatic cancer.

The FDA grants Priority Review to medicines that, if approved, have the potential to offer significant improvement compared to marketed products or provide a treatment where no adequate therapy exists. The goal for completing a Priority Review is six months. The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ABRAXANE is set for September 21, 2013.

In April 2013, the European Medicines Agency (EMA) has also accepted for review a Type II Variation to the current Marketing Authorization Application (MAA) for ABRAXANE, in combination with gemcitabine, for the first–line treatment of patients with advanced pancreatic cancer. Celgene plans to submit dossiers for registration in other countries/regions during 2013.

Both applications included data from an open-label, phase III, randomized, international study, Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) involving 861 patients with metastatic pancreatic cancer. Results from this study were recently presented at the American Society of Clinical Oncology’s (ASCO) 2013 Gastrointestinal Cancers Symposium in January.

Celgene is preparing a development plan for a phase III, international, multicenter, randomized controlled trial evaluating the activity of ABRAXANE plus gemcitabine in the adjuvant pancreatic cancer setting.

ABRAXANE is not currently approved for the treatment of advanced pancreatic cancer.

Pancreatic cancer is the eighth leading cause of cancer-related death worldwide. The pancreas is composed of two main cell types: exocrine and endocrine. Exocrine tumors are by far the most common type of pancreatic cancer, with adenocarcinoma accounting for about 95 per cent of cancers of the pancreas. For all stages of pancreatic cancer combined, the five-year overall survival rate is about six per cent, which is the lowest five-year overall survival rate of any cancer in the US. In Europe, the reported survival rate is less than 10 per cent survival at five years.

ABRAXANE is an albumin-bound form of paclitaxel that is manufactured using patented nab technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.

In the United States, ABRAXANE was first approved in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE is also approved in Canada, India, European Union/European Economic Area (EU/EEA), South Korea, China, Australia, Bhutan, United Arab Emirates, Nepal, New Zealand, Japan, Russia, Sri Lanka, and Argentina for the treatment of metastatic breast cancer.

In October 2012, ABRAXANE was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also approved in Japan and Argentina for the treatment of non-small cell lung cancer and is approved in Japan for the treatment of gastric cancer.

ABRAXANE is currently in various stages of investigation for the potential treatment of the following cancers: melanoma, bladder, ovarian, and expanded applications for breast, lung, and pancreatic cancer.

Celgene Corporation is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.