FDA Approves Chemotherapy Drug Ixempra For Advanced Breast Cancer

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry;  Breast Cancer
Article Date: 18 Oct 2007 - 4:00 PST

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The US Food and Drug Administration (FDA) has approved a new chemotherapy drug called Ixempra (ixabepilone) for the treatment of advanced breast cancer.

The announcement was made to the press by Bristol-Myers Squibb on 17th October, the maker of the new drug, who also said the drug will be available "within days".

The drug was approved to treat patients with locally advanced breast cancer or with cancer that has started spreading to other parts of the body (metastatic), and is resistant or refractory to anthracyclines, taxanes, and capecitabine.

The FDA has also approved Ixempra for use with Xeloda (capecitabine) for two particular types of patient. One is where the cancer has developed resistance to an anthracycline and a taxane, and the other is where the cancer has become resistant to taxane and there are medical reasons why anthracycline cannot be used.

Dr Linda Vahdat, Associate Professor of Clinical Medicine and Associate Attending Physician, New York-Presbyterian Hospital/Weill Cornell Medical Center, said:

"Previously, patients with aggressive metastatic or locally advanced breast cancer no longer responding to currently available chemotherapies had limited treatment options."

"The approval of Ixempra means that we now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies."

Medical professionals are advised to exercise caution when administering Ixempra to patients with a history of heart disease, said the drug company. And the drug should not be used at all to treat pregnant women, or with Xeloda in patients with liver problems.

Ixempra is a type of drug known as a microtubule inhibitor and belongs to a class of antineoplastic agents, called the epothilones. Microtubules are essential for cell growth and division, so the drug acts by inhibiting this function in cancer cells. Studies with epothilones suggest this new class of chemotherapy drug could be more effective than the taxanes.

The FDA approval was granted on the efficacy and safety evidence of two multi-centre multinational trials involving nearly 880 patients. The trials evaluated the drug either on its own or in combination with Xeloda (capecitabine) in patients with locally advanced or metastatic breast cancer.

The most common adverse events reported by patients in the trials who received Ixempra included peripheral sensory neuropathy (nerve damage, with numbness and tremors), asthenia (weakness), fatigue, muscle pain, joint pain, loss of hair, nausea, vomiting, diarrhea. Those receiving the combination therapy also reported hand-foot syndrome, anorexia, abdominal pain, and constipation.

Click here for more detailed report on the trials.

Written by: Catharine Paddock


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