Abraxane drug gets FDA approval for patients with advanced pancreatic cancer

Sep 7 2013

Abraxane now part of standard-of-care for patients with advanced pancreatic cancer, following studies at the Virginia G. Piper Cancer Center at Scottsdale Healthcare

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).

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 percent.

"Although a two month increase in median survival may not seem like much, it is a critical milestone and, even more important is the significantly improved odds for patients surviving at least one and two years.  Previously very few survived one year and now we are seeing a meaningful chance of surviving one and two years.  This brings real hope for even better outcomes in the future for this terrible disease," said Dr. Mark Slater, vice president of Research and chief executive of the Scottsdale Healthcare Research Institute.

"This is a great example of Scottsdale Healthcare Research Institute's collaborative approach of having leading researchers, community physicians and clinical teams working together to develop new therapies and innovative treatments that benefit patients here in Arizona and across the United States," added Ron Korn, M.D., medical director of the Virginia G. Piper Cancer Center at Scottsdale Healthcare.

Pancreatic cancer is the nation's fourth leading cause of cancer-related death, responsible this year for an estimated 45,000 new cases, and more than 38,000 deaths. There is no method of early detection, so pancreatic cancer patients often are not diagnosed until their cancer is in its advanced stages. Nearly 75 percent die within the first year of diagnosis, and fewer than 6 percent survive more than 5 years.

"Pancreatic cancer incidence is increasing worldwide, and we are optimistic that this will have an impact for treating advanced pancreatic cancer," added Ramesh Ramanathan, M.D., medical director of Virginia G. Cancer Center Clinical Trials at Scottsdale Healthcare and MPACT principal investigator for the United States.

Today's approval of Abraxane by the FDA as a front-line treatment of pancreatic cancer follows years of clinical trials, including those managed by Translational Drug Development (TD2), the pharmaceutical-development subsidiary of TGen.

"We are proud to have helped navigate the regulatory requirements and study protocols that helped ensure that Abraxane was not only effective, but also safe for patients with advanced pancreatic cancer," said Dr. Stephen Gately, President and CEO of TD2. "This is one of the most significant advancement in the treatment of pancreatic cancer since the FDA approved gemcitabine in 1996."

Dr. Von Hoff, considered among the nation's leading authorities on pancreatic cancer, also was the principal investigator for the first clinical trial of gemcitabine, the first therapy to show improvement in survival for patients with pancreatic cancer.

The pancreas is a glandular organ behind the stomach that secretes enzymes to help digestion, and produces hormones, including insulin, which helps regulate blood-sugar metabolism. 

Abraxane wraps traditional chemotherapy, paclitaxel, in near-nano sized shells of albumin, a protein that the tumor recognizes as food. Once inside the tumor, the Abraxane acts like a "Trojan Horse" to release chemotherapy and kill the cancer cells.

Abraxane, made by Celgene Corporation, previously was approved by the FDA for use in the treatment of metastatic breast cancer and advanced lung cancer.