Abraxane has been approved for the treatment of late-stage pancreatic cancer, bringing a new treatment option to the arsenal for patients whose pancreatic cancer has metastasized, the New York Times reported on Sept. 6.
Abraxane was approved on Friday by the Food and Drug Administration after a clinical trial showed that it extended the lives of patients with pancreatic cancer by a little less than two months.
While that might seem like a modest improvement with Abraxane, it offers a new option for pancreatic cancer, which is historically very difficult to treat with few options, especially in later stages. Patients with metastatic pancreatic cancer usually live only about six months.
Pancreatic cancer is the fourth leading cause of cancer death in the United States. An estimated 45,220 patients will be diagnosed and 38,460 will die from the disease in 2013, according to the National Cancer Institute, the FDA said in a press release about the Abraxane approval.
Before Abraxane was approved for the new use, the FDA reviewed it under the agency’s priority review program, which provides for an expedited review of drugs. Abraxane, a chemotherapy drug, was also granted orphan product designation for pancreatic cancer because it is intended to treat a rare disease or condition, the FDA said.
Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) is intended to be used in combination with gemcitabine, another chemotherapy drug, in patients with pancreatic cancer that has spread to other parts of the body.
Abraxane, manufactured by Celgene, was approved to treat breast cancer in 2005. Abraxane also was approved to treat non-small cell lung cancer in 2012.