This article is more than 5 years old. Information may no longer be current.

FDA denies chemoprevention indication for dutasteride

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

This week, GlaxoSmithKline announced that the FDA has issued a Complete Response letter for their supplemental New Drug Application for dutasteride for prostate cancer chemoprevention.

A Complete Response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and it cannot be approved in its present form.

In December, 2010, the FDA’s Oncologic Drugs Advisory Committee rejected dutasteride (Avodart, GlaxoSmithKline) for this indication because the risk for more aggressive tumors outweighed the potential for chemoprevention.

The notification refers only to the supplemental file regarding an indication to reduce prostate cancer risk and not the existing FDA-approved uses. Dutasteride is currently approved to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The drug is designed to improve symptoms, reduce the risk for acute urinary retention and the need for BPH-related surgery. In combination with the alpha-blocker tamsulosin, dutasteride is also approved for the treatment of symptomatic BPH in men with an enlarged prostate.

Follow HemOncToday.com on Twitter.