WASHINGTON — The Food and Drug Administration on Monday expanded its approval of Johnson & Johnson’s prostate cancer pill, Zytiga, for men with an earlier stage of the disease.
The agency said Zytiga is now approved for late-stage prostate cancer patients who have not yet received chemotherapy, based on study results showing it can extend life by up to five months when taken by men in that group.
The FDA had in April 2011 approved the drug for men with prostate cancer who have already taken the chemotherapy drug docetaxel.
Zytiga works by decreasing the male hormone testosterone. Testosterone stimulates the growth of prostate tumors, and treatment often includes administering drugs aimed at cutting the body’s testosterone production.
In a study, the typical patient taking Zytiga survived five months longer than the typical patient taking a fake pill, or placebo.