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.
About 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.
About Abraxane
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 most effective when used in combination with other medications like Gemzar® (gemcitabine) in patients with pancreatic cancer that has spread to other parts of the body.
Abraxane’s initial approval was based on data from the Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) study of Abraxane®. The study included 861 patients who were randomly assigned to receive Abraxane plus Gemzar or Gemzar alone. Results indicated that patients who received Abraxane and Gemzar had a median overall survival of 8.7 months, compared with 6.6 months for those who received Gemzar alone.
Abraxane also improved long-term survival, demonstrating a 59 percent increase in one-year survival, with 35 percent of patients alive at one year compared to 22 percent of those who received Gemzar alone. Abraxane doubled the two-year survival rate—10 percent of patients were still alive at two years, compared with 5 percent of those who had Gemzar alone. The extended analysis showed that Abraxane plus Gemzar demonstrated an improvement in the overall survival of patients compared to treatment with Gemzar alone for up to 3.5 years.1-5
Abraxane was well tolerated, though it did carry a significantly higher incidence of peripheral neuropathy (numbness in the fingers or toes) than Gemzar—17 percent versus less than 1 percent. This led to discontinuation of Abraxane in 8 percent of patients and to dose reduction in 10 percent. In addition, more patients in the Abraxane group experienced neutropenia (38% vs. 27%) and fatigue (17% vs 7%). Other side effects of Abraxane included thrombocytopenia, fatigue, hair loss, nausea, vomiting, fever, diarrhea, rash, and dehydration.
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.
References:
- FDA approves Abraxane for late-stage pancreatic cancer. [FDA News Release]. U.S. Food and Drug Administration website.
- Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. New England Journal of Medicine. 2013; 369(18): 1691-703.
- Von Hoff DD, et al. Promising clinical activity of a NAB paclitaxel plus gemcitabine combination in a disease-specific Phase I trial in patients with advanced pancreatic cancer. 2008 annual meeting of the American Association for Cancer Research. Abstract 4179.
- Von Hoff DD, Ervin TJ, Arena FP, et al. Randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT). Journal of Clinical Oncology. 2012; 30(suppl 34): Abstract LBA148.
- Goldstein D, El-Maraghi RH, Hammel P, et al. Analyses of updated overall survival (OS) and prognostic effect of neutrophil-to-lymphocyte ratio (NLR) and CA 19-9 from the phase III MPACT study of nab-paclitaxel (nab-P) plus gemcitabine (Gem) versus Gem for patients (pts) with metastatic pancreatic cancer (PC). J Clin Oncol 32:5s, 2014 (suppl; abstr 4027)
