The U.S. Food and Drug Administration (FDA) announced it has expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
Abraxane, marketed by Celgene, was first approved to treat breast cancer in 2005, and then non-small cell lung cancer in 2012.
The fourth leading cause of cancer death in the United States, pancreatic cancer has an extremely poor prognosis since most patients are not diagnosed until the cancer has advanced. As many as 45,220 patients will be diagnosed in the U.S. this year, and 38,460 will die from the disease, according to the National Cancer Institute.
Surgery is the only known curative option.
Said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research:
Patients with pancreatic cancer are often diagnosed after the cancer has advanced and cannot be surgically removed. In these situations, and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life.
A New Treatment Option
Abraxane is a chemotherapy drug that can slow the growth of certain tumors. It is intended to be used in combination with the chemotherapy drug gemcitabine in patients with pancreatic cancer that has spread to other parts of the body.
Not only did the FDA review this new use for Abraxane under the agency’s priority review program, it also granted Celgene orphan product designation for pancreatic cancer for Abraxane.
Abraxane's approval in this setting comes on the heels of a clinical trial with 861 participants randomly assigned to receive either Abraxane plus gemcitabine or gemcitabine alone.
Participants treated with Abraxane plus gemcitabine lived, on average, 1.8 months longer than those treated with gemcitabine alone.
The common side effects observed in Abraxane plus gemcitabine-treated participants is too long to list here. Interested readers should visit www.abraxane.com to see the full list of side effects direct from the manufacturer's label.
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