Janssen-Cilag receives approval for Zytiga in Europe

Janssen-Cilag has been granted approval from European healthcare regulators for the sale of its new oncology therapy option Zytiga (abiraterone acetate).

The European Commission has ratified the marketing authorisation application for the new androgen biosynthesis inhibitor as a therapy for metastatic castration-resistant prostate cancer, in combination with prednisone or prednisolone.

It follows an accelerated regulatory review process by the European Medicines Agency and a recommendation from the Committee for Medicinal Products for Human Use, based on positive data from phase III trials.

Zytiga becomes the first oral treatment for metastatic castration-resistant prostate cancer that has been shown to inhibit androgen production at all three sources.

Professor Karim Fizazi of the department of cancer medicine at Institut Gustave Roussy, one of the drug's phase III investigators, said: "The European Commission approval of abiraterone acetate gives new hope to men who are suffering from this late stage of prostate cancer with very few treatment options left."

Janssen is also currently in the process of seeking European approval for the HIV therapy Edurant, which showed its efficacy in phase III study data published in July.