ZYTIGA is indicated with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see Pharmacology: Pharmacodynamics under Actions); the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
ZYTIGA is also indicated in combination with prednisone or prednisolone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) who may have received up to 3 months of prior ADT.