The Pharmaceutical Journal
Vol 271 No 7275 p671
15 November 2003

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Casodex 150 mg (bicalutamide): no longer indicated for treatment of localised prostrate cancer (more)
Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk)

Casodex licence for localised prostate cancer withdrawn

Patients being treated with Casodex 150mg (bicalutamide) for localised prostate cancer should be reviewed as soon as possible and have their treatment discontinued, says the Medicines and Healthcare products Regulatory Agency.

The drug’s summary of product characteristics and licence have been updated following withdrawal of the indication for localised disease (see p673).

The licence withdrawal comes after the Committee on Safety of Medicines reviewed trial data which revealed a small increase in the number of deaths among patients treated with Casodex compared with patients given placebo.

Casodex 150mg remains indicated in locally advanced prostate cancer. Casodex 50mg, which is used in advanced prostate cancer, in unaffected by this licence change.