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Health Law and Regulation

STORY OF THE WEEK


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FDA Approves Ixempra for Advanced Breast Cancer Patients

Ixempra (ixabepilone), a new anti-cancer treatment, has been approved by the U.S. Food and Drug Administration (FDA) for use in patients with metastatic or locally advanced breast cancer who have not responded to certain other cancer drugs. The drug binds to cancer cell microtubules, which support and shape the cells as well as play a role in cell division. The FDA evaluated Ixempra under priority review, completing its assessment of the drug's safety and effectiveness in six months.

"This approval is important because it provides certain patients with a new chemotherapy option in instances where other drugs have failed," said Douglas C. Throckmorton, M.D., deputy director of the FDA's Center for Drug Evaluation and Research. "FDA is working every day to support the development of safe and effective new therapies that benefit patients in need."

The drug was approved to be used in combination with capecitabine, another cancer drug. It is to be used for patients who do not benefit from two other chemotherapy treatments—an anthracycline (such as doxorubicin or epirubicin) and a taxane (such as paclitaxel or docetaxel)—any longer. Ixempra was also approved for use in patients who no longer benefit from an anthracycline, a taxane and capecitabine, without being combined with capecitabine.

To access the safety and efficacy of Ixempra combined with capecitabine, 752 patients were evaluated in a random clinical trial. For the trial, Ixempra was compared to capecitabine alone. Results showed that the combination therapy demonstrated improvements in delaying cancer progression or death compared to capecitabine alone. A study of 126 patients assessed the safety and efficacy of Ixempra administered alone, and results showed that clinically significant tumor shrinkage occurred in 12 percent of the patients.

Side effects of Ixempra include peripheral neuropathy, bone marrow suppression, constipation, nausea, vomiting, muscle paint, joint pain, fatigue and general weakness. It is cautioned that women taking Ixempra should avoid taking drugs that are strong inhibitors of CYP3A4, one of the enzymes that metabolizes Ixempra. In addition, women who have had severe allergic reactions to drugs that contain Cremophor or its derivatives or women who have baseline bone marrow suppression should refrain from taking Ixempra for breast cancer treatment. Patients with moderate to severe liver impairment should not take Ixempra due to the increased risk of toxicity and death.

Source: U.S. Food and Drug Administration, October 22, 2007


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IMPORTANT NOTICE: This information is designed to provide accurate and authoritative information on the business of healthcare. It is distributed with the understanding that Healthcare Intelligence Network is not engaged in rendering legal advice. If legal advice is required, the services of a competent professional should be retained.



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