Reuters) Mar 09 - Johnson & Johnson's prostate cancer drug Zytiga (abiraterone acetate) plus prednisone improved survival of asymptomatic or mildly asymptomatic men with metastatic castration-resistant prostate cancer (CRPC) who have not received chemotherapy, the company said on Thursday.
An independent data monitoring committee unanimously recommended that patients receiving a placebo in the phase III trial be offered treatment with Zytiga, the company said.
The study included 1,088 men who were randomized to receive Zytiga 1,000 mg once a day plus prednisone 5 mg twice a day, or placebo plus prednisone. The primary endpoints of the study are radiographic progression-free survival and overall survival, and the company said in a press release there is "evidence of clinical benefit as well as continued evidence of favorable safety" in the treated patients.
Zytiga is not yet approved for metastatic CRPC not yet treated with chemotherapy. The company said it plans to submit for regulatory approval in the U.S., Europe and elsewhere later this year.
Presently the drug is approved in combination with prednisone for patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel. J&J noted in a press release yesterday that the phase III trial for that indication was also stopped early.
Zytiga costs approximately $5,000 per month.
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