FDA approves ABRAXANE chemotherapy drug for treatment of metastatic pancreatic cancer

Pancreatic Cancer Action NetworkSep 7 2013

The Pancreatic Cancer Action Network is pleased to announce that today ABRAXANE® was approved by the U.S. Food and Drug Administration (FDA) to treat metastatic pancreatic cancer.  ABRAXANE is intended to be used with gemcitabine, another chemotherapy drug that has been the standard of care, in patients with pancreatic cancer that has spread to other parts of the body.  The FDA approval of ABRAXANE is the first new treatment to be approved for adenocarcinoma pancreatic cancer in nearly eight years.

"We are pleased that patients with advanced pancreatic cancer now have a new treatment option helping to expand the treatment landscape for the fourth leading cause of cancer death in the United States," said Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network. "With a five year survival rate of just six percent, the FDA approval of ABRAXANE is an important step for a disease that desperately needs treatment advances to improve patient outcomes. The Pancreatic Cancer Action Network will continue to work with the medical community to build upon this success and reach our goal to double the survival rate for pancreatic cancer by 2020."

This approval follows the clinical trial results announcement of January 2013. ABRAXANE was previously approved for breast cancer in 2005 and in October 2012 was approved for a type of lung cancer. It is a form of the chemotherapy drug paclitaxel that is modified by the addition of a human protein called albumin. The combination of ABRAXANE with gemcitabine improved overall survival in patients with metastatic pancreatic cancer by nearly two months (8.5 months vs. 6.7 months) when compared with gemcitabine alone during the phase III clinical trial. Also, a 59 percent increase in one-year survival was reported.  This success also illustrates that clinical trials are the mechanism that enables improvements in patient outcomes.   

"The FDA approval of ABRAXANE for metastatic pancreatic cancer is an important milestone for patients. Our commitment to improving the lives of people diagnosed with this disease doesn't end here," said Markus Renschler, M.D., Corporate Vice President, Global Head of Hematology and Oncology Medical Affairs at Celgene Corporation. "Celgene will continue to pursue unique scientific approaches and invest in understanding the science behind pancreatic cancer, which may lead us to new therapeutic approaches, and importantly, support ways to improve the lives of people diagnosed with the disease."

The Pancreatic Cancer Action Network encourages all patients to consider clinical trials when exploring treatment options. The organization has a comprehensive up-to-date database of all approved pancreatic cancer-specific clinical trials taking place nationwide and can do a customized eligibility search for patients through our Patient and Liaison Services program.