FDA clears expanded indication of Janssen prostate cancer medication

11th December 2012 (Last Updated December 11th, 2012 18:30)

The US Food and Drug Administration (FDA) has approved an expanded indication of Janssen's Zytiga (abiraterone acetate) for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

The US Food and Drug Administration (FDA) has approved an expanded indication of Janssen's Zytiga (abiraterone acetate) for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

The approval enables the use of Zytiga along with prednisone prior to chemotherapy in mCRPC patients.

Previously the oral, once-daily medication in combination with prednisone was indicated for mCRPC patients who have received prior chemotherapy containing docetaxel.

"The approval enables the use of Zytiga along with prednisone prior to chemotherapy in mCRPC patients."

UCSF Helen Diller Family Comprehensive Cancer Center clinical medicine associate professor and Phase III study lead investigator Dr Charles Ryan said the expanded indication for ZYTIGA provides physicians with an important tool for treating men with metastatic castration-resistant prostate cancer who have not received chemotherapy.

"ZYTIGA works by inhibiting the enzyme complex required for the production of androgens in the testes, adrenals and the prostate tumour tissue," Ryan said.

The approval is based on positive efficacy and safety data from a Phase III, randomised, double-blind, placebo-controlled study conducted in 1,088 subjects with mCRPC who failed androgen deprivation therapy and had not received cytotoxic chemotherapy.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has also announced a positive opinion for an expanded indication of Zytiga, which is under review by other health authorities worldwide.

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."