J&J files for second Zytiga marketing approval
NEW YORK (AP) — Johnson & Johnson said Wednesday that regulators will conduct a faster review of its prostate cancer pill Zytiga as the company seeks a new marketing approval.
The Food and Drug Administration will conduct a six-month review of Zytiga as a treatment for cancer in patients who have not received chemotherapy. The review means the FDA should finish its review, which began in June, in mid-December.
On June 15 the company's Janssen Research & Development unit said it asked the FDA to approve Zytiga as a treatment for prostate cancer that has metastasized and has few or no symptoms following androgen-deprivation therapy. The drug is approved for use in combination with the steroid prednisone. The FDA approved Zytiga in April 2011 for use in patients who had already been treated with a chemotherapy regimen that included the drug docetaxel.
Shares of Johnson & Johnson added 7 cents to $67.58 in morning trading.