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FDA approves drug tested by Scottsdale Healthcare and TGen
Date:9/6/2013

SCOTTSDALE, Ariz., Sept. 6, 2013 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Abraxane for patients with advanced pancreatic cancer, following 7 years of rigorous clinical trials overseen by Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

(Logo: http://photos.prnewswire.com/prnh/20120201/DC45876)

Abraxane, the brand name for nab-paclitaxel, was approved for use in combination with gemcitabine, the previous standard drug therapy, following a large scale international clinical trial headed by Dr. Daniel D. Von Hoff, TGen Physician-in-Chief and Chief Scientific Officer at Scottsdale Healthcare's Virginia G. Piper Cancer Center Clinical Trials, a partnership of Scottsdale Healthcare and TGen.

"This is a new standard for treatment of metastatic pancreatic cancer that could become the backbone for other new treatment regimens," said Dr. Von Hoff, echoing the analysis he presented earlier this year at the annual meeting of the American Society of Clinical Oncology (ASCO). "The fact that Abraxane plus gemcitabine demonstrated an overall survival benefit is a significant step forward in offering new hope for our patients."

Dr. Von Hoff was the Principal Investigator of MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), the Phase III clinical study of 861 cancer patients at 121 sites in North America, Europe and Australia.

The study found that the combination of Abraxane and gemcitabine extended median overall survival by nearly 2 months, compared to gemcitabine alone — extending median survival to 8.5 months, from 6.7 months. The one-year median survival of patients increased to 35 percent, from 22 p
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SOURCE Scottsdale Healthcare
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