EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Commission (EC) has granted approval for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer.

During the last few decades, little progress has been made in improving outcomes for patients diagnosed with pancreatic cancer. According to the European Cancer Observatory, 78,654 people were diagnosed with pancreatic cancer in the EU in 2012, and 77,940 died that same year. The mortality of pancreatic cancer is high, making it the fourth deadliest cancer for both men and women. Patients diagnosed with metastatic disease have a median life expectancy, after diagnosis, of approximately three to six months. There have been no new medications approved for pancreatic cancer in nearly seven years.

"With such low survival rates for this disease, the situation for patients and their families is really very poor. But now, we have been able to show that the addition of nab-paclitaxel to conventional treatment with gemcitabine provides substantial benefits in overall survival, with manageable side effects," said Josep Tabernero, MD, Head of the Medical Oncology Department at the Vall d'Hebron Institute of Oncology and the Vall d'Hebron University Hospital in Barcelona, Spain, and a primary investigator for the MPACT trial. "My perception is that this approval is going to mandate a change in the way that we treat patients, offering a new option with a good efficacy and safety profile."

Alan Colowick, MD, President of Celgene Europe, the Middle East and Africa (EMEA), added: "ABRAXANE in combination with gemcitabine is the first treatment in Europe to be approved for pancreatic cancer in nearly seven years. In fact, since 1990, more than 30 Phase III trials have failed to lead to regulatory approval in the European Union for advanced or metastatic pancreatic cancer. Today's announcement is a significant step forward, but it is by no means the end for Celgene. We remain committed to developing innovative treatments to improve the lives of those with this devastating disease."

The EC decision was based on the results of the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, Phase III, randomized, international study published in the New England Journal of Medicine in its 31 October 2013 edition. The MPACT study involved 861 chemotherapy-naïve patients with metastatic pancreatic cancer at 151 community and academic centers from 11 countries, including North America, Eastern and Western Europe, and Australia. In the study, ABRAXANE plus gemcitabine demonstrated a statistically significant improvement in median overall survival compared to gemcitabine alone (8.5 vs. 6.7 months) (HR 0.72, P<0.0001); a 28% overall reduction in risk of death.

Grade 3 and higher adverse events that were reported more often with ABRAXANE plus gemcitabine versus gemcitabine alone were neutropenia, fatigue, and peripheral neuropathy.

The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in November 2013.

ABRAXANE will be launched in the European Union in the coming months according to local requirements.