Celgene International Sàrl, an unit of Celgene Corp. (CELG), said that the European Commission or EC has granted approval for ABRAXANE in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer.
The EC decision was based on the results of the Metastatic Pancreatic Adenocarcinoma Clinical Trial or MPACT, an open-label, Phase III, randomized, international trial. The MPACT study comprised 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. The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use in November 2013.
In the study, ABRAXANE plus gemcitabine showed a statistically significant improvement in median overall survival versus gemcitabine alone; a 28% overall reduction in death risk.
In the last few decades, little progress was 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.
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