FDA Approves Nab-Paclitaxel for Late-Stage Pancreatic Cancer


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The U.S. Food and Drug Administration (FDA) has expanded the approved uses of paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abraxane) to treat patients with late-stage pancreatic cancer.

“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 [nab-paclitaxel] can help prolong a patient’s life.”

Nab-paclitaxel is a chemotherapy drug that can slow the growth of certain tumors. The agent is intended to be used with gemcitabine in patients with metastatic pancreatic cancer.

The FDA reviewed the new use for nab-paclitaxel under the agency’s priority review program, which provides for an expedited review of drugs. Nab-paclitaxel was also granted orphan product designation for pancreatic cancer because it is intended to treat a rare disease or condition.

Clinical Trial

The safety and effectiveness of nab-paclitaxel for pancreatic cancer were established in a clinical trial with 861 participants who were randomly assigned to receive nab-paclitaxel plus gemcitabine or gemcitabine alone. Participants treated with nab-paclitaxel plus gemcitabine lived, on average, 1.8 months longer than those treated with gemcitabine alone. Additionally, participants who received nab-paclitaxel plus gemcitabine experienced a delay in tumor growth that was, on average, 1.8 months later than the participants who only received gemcitabine.

Common side effects observed in nab-paclitaxel plus gemcitabine–treated participants include neutropenia, thrombocytopenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, rash, and dehydration. The most common serious side effects were pyrexia, dehydration, pneumonia, and vomiting. Other clinically important serious side effects included sepsis and pneumonitis. 

Nab-paclitaxel was approved to treat breast cancer in 2005 and non–small cell lung cancer in 2012. ■



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