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There's good news for advanced breast cancer patients who haven't
responded to current chemotherapy drugs.
After a swift 6-month priority review, the Food and Drug
Administration put its stamp of approval on ixabepilone (IxempraTM), a new chemotherapy drug shown to reduce tumor size and slow tumor
growth in some patients with metastatic or locally advanced breast
cancer.
The new drug, developed by Bristol-Myers Squibb, is approved for use in
combination with another chemotherapy drug capecitabine, in patients
who haven't had success with an anthracycline (like doxorubicin or
epirubicin) and a taxane (like paclitaxel or docetaxel), and as a
standalone option for patients who have exhausted all 3 options (an
anthracycline, a taxane, and capecitabine).
The FDA review was based on studies of ixabepilone alone and
in combination with capecitabine. In a study of 126 breast cancer
patients who received ixabepilone alone, 12% saw a significant decrease
in the size of their tumors. In a randomized trial of 752 patients who
took both ixabepilone and capecitabine, tumor growth slowed
significantly compared to patients who were taking capecitabine alone.
Ixabepilone belongs to a class of drugs known as epothilone
analogs, which work by binding to and interfering with microtubules,
structures that play a key role in cell division. The net effect is a
slowing of the growth of cancer cells in the body.
Ixabepilone is given by intravenous infusion over 3 hours
every 3 weeks. One of the possible side effects of taking ixabepilone
is bone marrow suppression, so it is not recommended for patients who
have low white blood cell or platelet counts. Other possible side
effects include numbness or tingling in the hands or feet,
constipation, nausea, vomiting, and muscle and joint pain.
ACS News Center stories are provided as a source of cancer-related
news and are not intended to be used as
press releases.
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