Celgene’s Abraxane given European approval for pancreatic cancer

US biotech company Celgene’s (Nasdaq: CELG) European subsidiary today announced that the European Commission 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 pancreatic cancer.

The decision was based on the results of the open-label, Phase III MPACT study. It involved 861 chemotherapy-naive 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 versus 6.7 months) – a 28% overall reduction in risk of death. The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in November. The cancer drug was also approved for pancreatic cancer by the US Food and Drug Administration last year.

Alan Colowick, president of Celgene Europe, the Middle East and Africa (EMEA), said: “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.”