Approved October 2007
Cancer & Oncology
Ixempra (ixabepilone) is a semi-synthetic analog of epothilone B. It binds to tubulin and promotes tubulin polymerization and microtubule stabilization, thereby arresting cells in the G2-M phase of the cell cycle and inducing tumor cell apoptosis.
Ixempra is specifically indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Ixempra monotherapy is specifically indicated for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.
Ixempra is supplied as as a solution designed for intravenous administration. The recommended initial dose is is 40 mg/m2 administered intravenously over 3 hours every three weeks. Doses for patients with body surface area greater than 2.2 m2 should be calculated based on 2.2 m2.
FDA approval of Ixempra was based on the results of two clinical trials.
This open-label trial enrolled 752 subjects whose disease had rapidly progressed through at least two prior therapies (anthracycline and taxane). Subjects were randomized to receive ixabepilone (40 mg/m2 every 3 weeks) in combination with capecitabine (1000 mg/m2 twice daily for 2 weeks followed by 1 week rest) or capecitabine alone. The combination treatment prolonged progression free survival compared to capecitabine alone (5.7 months vs. 4.1 months), with a statistically significant 25% decrease in the risk of disease progression. An objective response rate was observed in more than twice as many subjects in the combination group compared to control (34.7% vs. 14.3%). The median duration of response was 6.4 months versus 5.6 months.
This single-arm trial enrolled 126 women who had heavily pretreated, advanced metastatic breast cancer, which had progressed through following two or more chemotherapy regimens including an anthracycline, a taxane, and capecitabine. Ixempra was administered at a dose of 40 mg/m2 intravenously over 3 hours every 3 weeks, for a median of 4 cycles. The primary endpoint was objective response rate. Secondary endpoints included duration of response and time to response. Of the enrolled subjects, 113 were response-evaluable. Response results were determined by an independent radiology facility (IRF) and study investigators. The objective response rate was 12.4% determined by the IRF and 18.3% determined by the investigators. Median duration of response was 6.0 months and median time to response was 6.1 weeks.
Adverse events associated with the use of Ixempra monotherapy may include, but are not limited to, the following:
The adverse events associated with the use of Ixempra/capecitabine combination treatment may include, but are not limited to, the following:
Ixabepilone is a semi-synthetic analog of epothilone B. Ixabepilone binds directly to ß-tubulin subunits on microtubules, leading to suppression of microtubule dynamics. Ixabepilone suppresses the dynamic instability of aß-II and aß-II microtubules. This arrests the cells in the G2-M phase of the cell cycle and induces tumor cell apoptosis.
For additional information regarding Ixempra or breast cancer, please visit the Ixempra web page.
The Ixempra (ixabepilone) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.