FDA Approves Bristol-Myers Squibb Breast Cancer Medication Abraxane
FDA on Friday approved Abraxane, a breast cancer medication manufactured by Bristol-Myers Squibb, for women in advanced stages of the disease who have not responded to chemotherapy, the New York Times reports (Pollack, New York Times, 1/8). FDA also approved Abraxane for women with breast cancer who relapse within six months of initial surgery and chemotherapy (Chicago Tribune, 1/8).
Abraxane is a reformulated version of the breast cancer medication Taxol, also manufactured by BMS, that eliminates certain side effects. In a clinical trial of 460 women with breast cancer, 21.5% of participants who received Abraxane experienced a reduction in the size of their tumors, compared with 11.1% of those who received Taxol. Participants who received Abraxane also had fewer cases of severe neutropenia, a decrease in white blood cells, the trial found.
However, the Abraxane label will include a "prominent warning" about neutropenia, the Times reports. Abraxane also has a risk of nerve damage, severe muscle or joint pain and vomiting. BMS has not released data from the trial on whether Abraxane extended the lives of participants.
Taxol, which is sold under the generic name paclitaxel, is dissolved in a toxic solvent that causes side effects "beyond those caused by the drug itself," the Times reports. In contrast, Abraxane is made from particles of paclitaxel attached to the blood protein albumin. Patients who take Taxol also receive steroids and antihistamines, which also can result in side effects (New York Times, 1/8).
Physicians must administer Taxol to patients through special tubes because the medication can cause chemicals in plastic to enter the body (Hamilton, Wall Street Journal, 1/10). Abraxane allows patients to take the medication without a solvent, steroids or antihistamines. In addition, physicians can administer Abraxane to patients in larger doses "before side effects become intolerable," the Times reports.
BMS, which likely will begin to market Abraxane within 45 days, has not set a price for the medication. According to the Times, the price of Abraxane "is expected to be fairly high" compared with the price of Taxol. BMS likely will highlight that Abraxane eliminates the cost of steroids and special tubes.
Analysts called the FDA approval of Abraxane "a vindication" for Patrick Soon-Shiong, executive chair of American Pharmaceutical Partners, which will market the medication, the Times reports. Soon-Shiong has faced concerns from some investors that the medication would not receive FDA approval (New York Times, 1/8).