J&J seeks expanded Zytiga label

Johnson & Johnson (NYSE:JNJ) submitted regulatory applications to FDA and EMA for Zytiga abiraterone acetate to treat chemotherapy-naive patients with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly asymptomatic after failing androgen deprivation therapy. J&J reported earlier this month that Zytiga met the co-primary endpoint of radiographic progression-free survival (PFS) vs. prednisone alone in a Phase III trial in the indication (see BioCentury, June 11). ...