Janssen's Zytiga indicated for metastatic castration-resistant prostate cancer(mCRPC),has won FDA approval for use in patients who have not received chemotherapy.
The oral,once-daily medication was previously used in combination with prednisone to treat mCRPC patients who have received prior chemotherapy containing docetaxel.
The UCSF Helen Diller Family Comprehensive Cancer Center clinical medicine associate professor and the pivotal Phase 3 study lead investigator Charles Ryan said,"ZYTIGA works by inhibiting the enzyme complex required for the production of androgens in the testes,adrenals and the prostate tumour tissue."
Approval is based on positive efficacy and safety data from Phase 3,randomised placebo-controlled study conducted in 1,088 mCRPC subjects who failed androgen deprivation therapy and had not received chemotherapy.
The European Medicines Agency's Committee for Medicinal Products for Human Use has also announced a positive opinion for an expanded indication of Zytiga that is under review by other health authorities across the world.
Janssen Biotech president Robert Bazemore said,"We are delighted ZYTIGA is now approved for men with metastatic castration-resistant prostate cancer earlier in the course of their disease,before chemotherapy,where there continues to be a need for additional treatment options."
