SUMMIT, NJ — The approved uses of Abraxane — paclitaxel protein-bound particles for injectable suspension, albumin-bound — have been expanded by the Food and Drug Administration to treat patients with metastatic pancreatic cancer in late stages.
“Patients with pancreatic cancer are often diagnosed after the cancer has advanced and cannot be surgically removed,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “In these situations, and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life.”
Abraxane is intended to be used in conjunction with gemcitabine in patients with metastatic pancreatic cancer. Its expanded usage was considered under the FDA’s priority review program, which provides for an expedited review of drugs. Abraxane also was granted orphan product designation for pancreatic cancer because of its use in rare diseases or conditions.
A clinical trial with 861 participants who were randomly assigned to receive Abraxane plus gemcitabine or gemcitabine alone was used to establish Abraxane’s safety and effectiveness for pancreatic cancer treatment. Participants treated with the combination of the two drugs lived an average 1.8 months longer than those treated with gemcitabine alone, while also experiencing a delay in progression-free survival that was, on average, 1.8 months later than the participants receiving the single therapy.
Pyrexia, dehydration, pneumonia and vomiting were the most common serious side effects reported, with other clinically important serious side effects including sepsis and pneumonitis. Common side effects observed in Abraxane plus gemcitabine-treated participants include neutropenia, thrombocytopenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea and rash.
Abraxane previously was approved to treat breast cancer in 2005 and non-small cell lung cancer in 2012. It is marketed by Celgene, based in Summit, NJ, while gemcitabine is marketed by Indianapolis-based Eli Lilly.