Janssen’s Zytiga approved in new prostate cancer indication

Janssen has been granted approval from the European Commission for the use of its drug Zytiga in a new prostate cancer indication.

The regulator has ratified the drug for use in combination with prednisone or prednisolone against metastatic castration-resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and who have not yet received chemotherapy.

It means more patients will be able to benefit from the drug, which was previously only indicated for mCRPC sufferers whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

This follows the publication of data from a phase III trial showing the survival benefits Zytiga can provide for this patient group, which led the Committee for Medical Products for Human Use of the European Medicines Agency to recommend the drug for approval in November 2012.

Jane Griffiths, chairman for Janssen's Europe, Middle East and Africa, said: "This decision by the European Commission is hugely welcomed news. It marks another important step forward in the treatment of men with advanced castration-resistant prostate cancer."