J&J scores two firsts for Erleada approval

FDA approved an NDA for Erleada apalutamide (JNJ56021927) from Johnson & Johnson (NYSE:JNJ) to treat non-metastatic castration-resistant prostate cancer (CRPC), making it the first approved drug for the indication and the first approval based on a metastatic-free survival (MFS) primary endpoint, according to FDA. The approval comes ahead of the drug's April PDUFA date.

Last week, J&J said Erleada plus androgen deprivation therapy (ADT) met the primary endpoint of significantly improving MFS vs. placebo plus ADT in the Phase III SPARTAN trial in 1,207 patients with non-metastatic CRPC (40.5 vs. 16.2 months, HR=0.28, 95% CI: 0.23, 0.35, p<0.0001) (see BioCentury Extra, Feb. 6)...