CHMP recommends Abraxane for Adenocarcinoma of the Pancreas-Celgene

Celgene International S�rl, a wholly-owned subsidiary of Celgene Corporation announced that the European Medicines Agency�s (EMA): Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion 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.

The CHMP positive opinion 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 16 October 2013 e-publication. In the study, nab-paclitaxel 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.>