U.S. FOOD AND DRUG ADMINISTRATION APPROVES ABRAXANE® IN COMBINATION WITH GEMCITABINE AS FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC PANCREATIC CANCER
-Approval Based on MPACT Study of ABRAXANE in Combination with Gemcitabine Demonstrating a Clinically Meaningful Increase in Overall Survival-
-First New Treatment Approved for Metastatic Adenocarcinoma of the Pancreas in Nearly 8 Years-
SUMMIT, New Jersey– (September 6, 2013) – Celgene Corporation (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as first–line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. Adenocarcinoma, a sub-type of exocrine tumors, accounts for about 95% of cancers of the pancreas.
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Abraxane, a microtubule inhibitor, is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles…
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