FDA OKs Ixempra for breast cancer

US drug major Bristol-Myers Squibb says that the US Food and Drug Administration has approved its drug Ixempra (ixabepilone) as a monotherapy for patients suffering from metastatic breast cancer. Specifically, the agent has been cleared for individuals in whom the disease is resistant or refractory to anthracycline, taxane or capecitabine-based treatment.

The FDA, which accepted Ixempra for priority review earlier this year (Marketletter July 2), based its decision on data from two multicenter trials which examined it as both a monotherapy and in combination with capecitabine in women with metastatic or locally-advanced breast cancer. In the monotherapy study, results showed that the drug achieved an objective partial response of 12.4%, a measure of tumor shrinkage, in 113 evaluable patients.

The second trial, which compared Ixempra plus capecitabine with capecitabine alone in 752 breast cancer patients who had demonstrated tumor resistance, showed that the combined regimen brought about a statistically-significant improvement in progression-free survival. On average, subjects who received Ixempra plus capecitabine survived for 5.7 months, versus a mean 4.1 months in the capecitabine alone cohort.