FDA okays J&J prostate cancer drug for pre-chemotherapy use

Mon Dec 10, 2012 1:38pm EST

Dec 10 (Reuters) - U.S. health regulators on Monday expanded the approval of Johnson & Johnson's drug Zytiga for advanced prostate cancer to allow its use prior to treatment with chemotherapy.

The expanded Food and Drug Administration approval, which came after the company demonstrated that Zytiga could extend survival if used prior to chemotherapy, could significantly boost sales of the new medicine.

Zytiga was originally approved in November 2011 to treat men whose prostate cancer had progressed following treatment with the chemotherapy drug docetaxel.

"Today's approval demonstrates the benefit of further evaluating a drug in an earlier disease setting and provides patients and health care providers the option of using Zytiga earlier in the course of treatment," Richard Pazdur, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, said in a statement.