NEW YORK All patients in a study of a Johnson & Johnson drug for advanced prostate cancer will be offered the medicine after an independent monitoring committee found it demonstrated an improvement in patient survival.
The monitoring committee recommended that patients in the placebo arm of the Phase III trial be offered treatment with abiraterone acetate, according to a division of Cougar Biotechnology, which was acquired by J&J.
A program to provide early access to abiraterone acetate for patients who meet specified medical criteria is being initiated, the company said on Thursday.
The study included 1,195 patients with advanced metastatic prostate cancer whose disease had progressed following treatment with one or two chemotherapy regimens.
Patients in the study received either the J&J drug plus the steroid prednisone or a placebo plus prednisone.
Independent data monitoring committees routinely oversee clinical trials to look for signs of safety problems that would lead to a study being halted, or for evidence that a drug works so well that it would be unethical not to offer it to patients receiving other medicines.
Data from the study will be presented at a European cancer meeting in Milan next month, the company added.
(Reporting by Bill Berkrot; Editing by Tim Dobbyn)