Gil Roth01.07.14
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corp., received approval from the European Commission (EC) 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.
The EC decision was based on the results of MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, Phase III, randomized, international study published in the New England Journal of Medicine in its October 31 2013 edition. The 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).
Abraxane will be launched in the EU in the coming months according to local requirements.
The EC decision was based on the results of MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, Phase III, randomized, international study published in the New England Journal of Medicine in its October 31 2013 edition. The 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).
Abraxane will be launched in the EU in the coming months according to local requirements.