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FDA Approves New Drug, Abraxane, for Treatment of Advanced Breast Cancer (dateline January 16, 2005)

In January 2005, the U.S. Food and Drug Administration (FDA) approved the use of the drug, Abraxane to help treat women with advanced, metastatic breast cancer —the type of cancer that has spread past the breast and lymph nodes to other areas of the body. The drug can be used in women who have been unsuccessfully treatment with combination chemotherapy or who have relapsed within 6 months of chemotherapy. Abraxane is a new form of the drug, Taxol (generic name, paclitaxel) that may have fewer side effects.

In a clinical trial comparing Abraxane and Taxol, 460 eligible women with advanced breast were given either drug. Those who received Abraxane saw their tumors shrink by 21.5% compared with 11.1% among the women who received Taxol.

"Abraxane provides a much-needed new treatment option for women with metastatic breast cancer," said lead clinical trial investigator William J. Gradishar, MD, Associate Professor of Medicine at the Lynn Sage Breast Cancer Program, Northwestern Memorial Hospital, in an American Pharmaceutical Partners news release. "The pivotal clinical trial results demonstrated that Abraxane had superior response rate when compared to Taxol in patients with metastatic breast cancer."

Taxol has been approved by the FDA for several years to treat breast cancer. However, it must be dissolved in a toxic solvent before administration, which causes allergic reactions in some patients. To counteract these reactions, steroids and antihistamines are given to patients before treatment.

According to American Pharmaceutical Partners, Inc., the marketer of Abraxane, its drug contains no toxic substances and does not require any premedication, as with Taxol. Abraxane belongs to a new class of drugs of "protein-bound particle" drugs. Patients who receive Abraxane can receive larger doses of the drug before it becomes intolerable.

In the clinical trial, slightly fewer women who took Abraxane experienced neutropenia—a condition marked by a sharp decrease in white blood cells—compared to those who took Taxol (82% to 80% respectively). Neutropenia can increase the risk of infection. However, patients on both drugs are warned that neutropenia is a possible side effect.

Other side effects noted in the clinical trial for both Abraxane and Taxol included anemia, infections, swelling, nausea, vomiting and diarrhea. Patients on Abraxane experienced more cases of nerve damage, severe pain in the muscles or joints, and vomiting than patients on Taxol.

"It's important that the entire breast cancer community constantly challenge the status quo and push each other to provide a better treatment for those with the disease," said Marisa Weiss, MD, oncologist, an American Pharmaceutical Partners news release. "This advance represents an exciting new treatment option for women with metastatic breast cancer."

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