European regulators have granted another approval for Celgene Corp’s Abraxane, this time for pancreatic cancer.
The European Commission has given the green light to a combination of Abraxane (nab-paclitaxel) and current standard of care gemcitabine (Eli Lilly’s Gemzar) for first-line treatment of adults with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer. The approval is based on a Phase III trial where Abraxane plus gemcitabine demonstrated a statistically significant improvement in median overall survival compared to gemcitabine alone (8.5 versus 6.7 months).
This latest approval (Abraxane has been available in Europe for breast cancer since 2008) is a major boost for patients who suffer from a disease where mortality is high. Those with metastatic pancreatic cancer have a median life expectancy, after diagnosis, of three to six months and there have been no new medications approved in nearly seven years.
Josep Tabernero of the the Vall d’Hebron University Hospital in Barcelona and primary investigator for the aforementioned Phase III trial, said that with such low survival rates “the situation for patients and their families is really very poor”. However he added: “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.”
The European thumbs-up follows a pancreatic cancer approval granted by the US Food and Drug Administration in September. US regulators approved Abraxane for breast cancer in 2005 and for non-small cell lung cancer in 2012.
