The Lynx Group

Abraxane Receives New Indication for Metastatic Pancreatic Cancer

September 2013, Vol 4, No 7

The US Food and Drug Administra­tion (FDA) approved a new indication for paclitaxel protein-bound particles for injectable suspension, albumin-bound (Abraxane; Celgene) for the treatment of patients with metastatic pancreatic cancer. Removal of the pancreas by surgery is the only curative option in pancreatic cancer, but this option is no longer useful by the time this type of cancer is diagnosed, when the cancer has metastasized.

“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 prolong a patient’s life.”

Paclitaxel protein-bound is a chemotherapy agent that has been shown to slow certain types of tumors.

The FDA approval of paclitaxel protein-bound for patients with pancreatic cancer was based on a clinical trial with 861 patients who were randomized to paclitaxel protein-bound plus gemcitabine (Gemzar) or to gemcitabine alone. The overall survival in patients receiving the combination therapy was an average of 1.8 months longer than in patients receiving gemcitabine alone. In addition, progression-free survival was also, onaverage, 1.8 months longer with the addition of paclitaxel protein-bound to gemcitabine than in patients receiving only gemcitabine. The common side effects with paclitaxel protein-bound include neutropenia, thrombocyto­penia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, fever, vomiting, rash, and dehydration. The most severe effects in this trial were fever, dehydration, pneumonia, and vomiting.

Paclitaxel protein-bound is already approved for the treatment of breast cancer and non–small-cell lung cancer. (September 6, 2013)

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