Celgene Corp. (CELG) announced that it has received approval from the U.S. Food and Drug Administration or FDA for its supplemental New Drug Application or sNDA of ABRAXANE in combination with gemcitabine as the first new treatment for patients with metastatic adenocarcinoma of the pancreas in nearly eight years.
Commenting on ABRAXANE, the company said it is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.
"For more than 15 years, treatment with gemcitabine has been the standard of care in this disease. The addition of ABRAXANE to gemcitabine demonstrated meaningful improvements across key efficacy outcomes, including overall survival, with a well-characterized safety profile," said Jean-Pierre Bizzari, M.D., Executive Vice President of Hematology and Oncology for Celgene Corporation.
Celgene stated that the FDA had granted ABRAXANE a Priority Review designation in May 2013 with a PDUFA date of September 21, 2013.
Also, in April 2013, the European Medicines Agency or EMA accepted for review a Type II Variation to the current Marketing Authorization Application for ABRAXANE, in combination with gemcitabine, for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, the company said.
The most common adverse reactions in the ABRAXANE/gemcitabine treatment group are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration.
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