1:37 PM
Feb 14, 2018
 |  BC Extra  |  Company News

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).

JNJ submitted an MAA to EMA last week for apalutamide to treat high-risk non-metastatic CRPC.

Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (Tokyo:4503) are developing Xtandi enzalutamide plus ADT in the same indication using MFS as a primary endpoint, which Xtandi met in the Phase III PROSPER trial. The partners have submitted regulatory applications to expand Xtandi's U.S. and EU labels to include non-metastatic CRPC (see BioCentury Extra, Feb. 5).

Erleada is a second-generation androgen receptor antagonist. Xtandi is an oral androgen receptor antagonist.

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