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Celgene Corp Receives Positive CHMP Opinion For Abraxane In Combination With Gemcitabine As Treatment For Patients With Metastatic Pancreatic Cancer

Friday, 22 Nov 2013 07:25am EST 

Celgene Corp 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 reviews applications for all 28 member states in the European Union (EU), as well as Norway and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months. There have been no new treatments approved for pancreatic cancer in nearly seven years. The CHMP positive opinion was based on the results of theMPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, phase III, randomized, international study published in the New England Journal of Medicine in its October 16, 2013 e-publication. The MPACT 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, 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.2 

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