Prostate Cancer

FDA panel requests more data on Casodex

Published in Cancer Weekly, January 21st, 2003

AstraZeneca Pharmaceuticals (AZN) announced that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) did not recommend approval of the new indication for Casodex 150 mg for the treatment of early stage prostate cancer.

The panel recommendation does not impact on the current use and approval of Casodex 50 mg formulation.

Although the advisory committee could not reach a consensus on the interpretation of the data and how the results from the trials apply specifically to U.S. patients, the committee did agree that the data appears to show Casodex 150 mg is a viable treatment option for patients in other regions...

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Source: Cancer Weekly (2003-01-21)

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