Dec 10 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
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.