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Article: FDA OKs Ixempra for breast cancer.
- Article from:
- Pharma Marketletter
- Article date:
- October 22, 2007
CopyrightCOPYRIGHT 2007 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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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, ...