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Janssen unblinds phase III trial of cancer drug Zytiga
Janssen has announced that its phase III study for the prostate cancer treatment Zytiga is being unblinded, based on the strong performance of the therapy thus far.
Study COU-AA-302 has evaluated Zytiga plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer who have not received chemotherapy.
An independent data monitoring committee has recommended unblinding the study based on an interim analysis showing the progression-free and overall survival benefits presented by Zytiga, as well as its strong safety profile.
Patients in the placebo arm of the trial will therefore now also be offered treatment with Zytiga, while Janssen will be able to use this data to support US regulatory approval of the drug in this specification.
Dr William Hait, global head for research and development at Janssen, said: "We're delighted that this data will soon be added to the growing body of literature about this important medication."
This comes after the All Wales Medicines Strategy Group recommended the drug for use among Welsh NHS prostate cancer patients last month.
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