• Most Popular
  • Most Shared

FDA staff question Glaxo drug for prostate cancer

Related Topics

Stocks

   

Mon Nov 29, 2010 6:56pm IST

* Staff reviewers note 'major issues'

* Glaxo seeks U.S. OK for new use to curb cancer risk

* FDA advisers meet Dec. 1

WASHINGTON, Nov 29 (Reuters) - U.S. regulatory staff have concerns about a number of issues with GlaxoSmithKline Plc's (GSK.L) (GSK.L) data in the company's bid to expand the use of its Avodart drug to help reduce the risk of prostate cancer in certain men.

Food and Drug Administration staff, in documents released ahead of a public advisory meeting on Wednesday, cited concerns about use of biopsies and the impact of the drug on black men, among other issues. (Reporting by Susan Heavey; Editing by Derek Caney)

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.