Janssen submits Zytiga for new prostate cancer approvals

Janssen has submitted its oncology therapy Zytiga for approval in a new indication for prostate cancer.

Marketing applications have been filed with the European Medicines Agency and US Food and Drug Administration for approval of the drug among metastatic castration-resistant prostate cancer patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy.

The submissions are based on positive data from a recent phase III clinical trial, which demonstrated the efficacy of Zytiga among this patient group when compared to placebo.

Dr William Hait, global head of Janssen research and development and head of the oncology therapeutic area, said: "These regulatory submissions for Zytiga are a clear example of our efforts to bring extraordinary oncologic therapies to those with the greatest need."

Earlier this month, the company announced phase III clinical trial data from a study of Stelara, demonstrating its efficacy in the treatment of psoriatic arthritis patients.