FDA Approval Likely for Ovarian Cancer Drug

On Friday (4-19), a Food and Drug Administration (FDA) advisory committee unanimously approved a new cancer drug to combat ovarian cancer. If approved by the FDA, Topotecan, manufactured by SmithKine Beecham Pharmaceutical, will be used to treat women with ovarian cancer after other treatments and chemotherapy have failed. The drug, which will be marketed as Hycamtin,” inhibits an enzyme that tumors need to grow and works inside the cancer cell to interrupt DNA replication. Hycamtin was shown to delay progression of ovarian cancer in late-stage patients for about 23 weeks — nine weeks longer than Taxol, a similar drug manufactured by Bristol-Myers Squibb. Taxol is already approved in 64 countries, including the U.S., where it is also approved for treating breast cancer.


The Nando Net and Bloomberg - April 19, 1996; The Nando Net and the Associated Press - April 19, 1996

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