The U.S. Food and Drug Administration (FDA) has approved Abraxane® (paclitaxel protein-bound particles for injectable suspension, albumin-bound) for the treatment of patients with metastatic pancreatic cancer.
Pancreatic cancer is one of the deadliest forms of cancer. Each year, approximately 45,000 people are diagnosed with pancreatic cancer in the United States and close to 38,000 die from the disease. The disease is often diagnosed at an advanced stage, and treatment of advanced disease remains challenging.
Abraxane is a novel form of the widely used cancer drug Taxol (paclitaxel). In Abraxane, the paclitaxel is bound to albumin, a human protein in tiny particles. This formulation improves the delivery of the drug directly to cancer cells and reduces side effects. It is intended to be used with Gemzar® (gemcitabine) in patients with pancreatic cancer that has spread to other parts of the body.
Abraxane’s approval was based on data from a study that established it’s safety and effectiveness. The study included 861 patients who were randomly assigned to receive Abraxane plus Gemzar or Gemzar alone. The results indicated that participants in the Abraxane group lived 1.8 months longer than those who only received Gemzar. What’s more, progression-free survival in patients who received Abraxane was 1.8 months longer than it was in those who received Gemzar alone.
Common side effects included neutropenia, thrombocytopenia, fatigue, peripheral neuropathy, hair loss, nausea, vomiting, fever, diarrhea, rash and dehydration. The most common serious side effects were fever, dehydration, pneumonia, and vomiting. Serious side effects included sepsis (bacterial infection in blood stream) and pneumonitis (inflammation of lung tissue).
Abraxane was approved as part of the FDA’s priority review program, which allows an expedited six-month review of drugs that may offer major advances in treatment. Abraxane was also granted orphan product designation for pancreatic cancer because it is intended to treat a rare disease or condition.
FDA approves Abraxane for late-stage pancreatic cancer. [FDA News Release]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367442.htm