BioCentury
ARTICLE | Clinical News

Zytiga abiraterone acetate regulatory update

July 2, 2012 7:00 AM UTC

The U.K.'s NICE issued final guidance recommending Zytiga abiraterone from Johnson & Johnson in combination with prednisone or prednisolone in patients with metastatic, castration-resistant prostate cancer (CRPC) that has progressed on or after docetaxel-containing therapy - the drug's approved indication. The decision is contingent upon J&J providing Zytiga at an undisclosed discount under a patient access scheme. The decision is in line with a May final appraisal determination, in which the agency reversed a prior negative decision after J&J submitted a revised patient access scheme, as well as information on how many patients could receive the drug (see BioCentury, May 21). ...