2007 > FDA Approves Ixempra for Advanced Breast Cancer Patients
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`FDA NEWS RELEASE
`FOR IMMEDIATE RELEASE
`October 22, 2007
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`2007
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`FDA Approves Ixempra for Advanced Breast Cancer Patients
`The U.S. Food and Drug Administration has approved Ixempra (ixabepilone), a new anti-cancer treatment, for use in patients with metastatic or locally advanced breast cancer
`who have not responded to certain other cancer drugs. The FDA evaluated Ixempra under priority review, completing its assessment of the drug's safety and effectiveness in six
`months.
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`"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."
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`Ixempra was approved for use in combination with another cancer drug, capecitabine, in patients who no longer benefit from two other chemotherapy treatments. These prior
`treatments included an anthracycline (such as doxorubicin or epirubicin) and a taxane (such as paclitaxel or docetaxel).
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`Ixempra was also approved for use alone in patients who no longer benefit from an anthracycline, a taxane and capecitabine.
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`According to the American Cancer Society, about 180,000 new cases of breast cancer are diagnosed each year in the United States. Metastatic breast cancer is the most
`advanced stage of breast cancer and has the potential to spread to almost any region of the body.
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`Ixempra has been shown to bind to cancer cell microtubules, which are structures within cells that help to support and shape them. Microtubules also play a role in cell division.
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`The safety and efficacy of Ixempra in combination with capecitabine were evaluated in 752 patients in a randomized clinical trial comparing the combination to capecitabine alone.
`This combination therapy demonstrated improvements in delaying cancer progression or death compared to capecitabine alone.
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`The safety and efficacy of Ixempra administered alone were evaluated in a study of 126 patients. Clinically significant tumor shrinkage occurred in 12 percent of the patients.
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`Ixempra's significant side effects included peripheral neuropathy (numbness, tingling or burning in the hands or feet) and bone marrow suppression. Other commonly observed
`toxicities included constipation, nausea, vomiting, muscle paint, joint pain, fatigue and general weakness.
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`Women taking Ixempra should avoid taking drugs that are strong inhibitors of CYP3A4, one of the enzymes that metabolizes Ixempra.
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`Ixempra should not be taken by women who have had severe allergic reactions to drugs that contain Cremophor or its derivatives, or by women who have baseline bone marrow
`suppression determined by low white blood cell or platelet count.
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`The combination of Ixempra and capecitabine should not be given to patients with moderate or severe liver impairment due to the increased risk of toxicity and death.
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`Ixempra is administered by intravenous infusion. It is distributed by Bristol-Meyers Squibb Company, Princeton, New Jersey.
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`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109015.htm[1/19/2015 4:46:23 PM]
`
`IMMUNOGEN 2221, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`2007 > FDA Approves Ixempra for Advanced Breast Cancer Patients
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`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109015.htm[1/19/2015 4:46:23 PM]
`
`IMMUNOGEN 2221, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`