J&J's Erleada meets in Phase III for castration-sensitive prostate cancer

Janssen Pharmaceuticals Inc. said a preplanned analysis by an IDMC showed that Erleada apalutamide met the dual primary endpoints in the Phase III TITAN trial to treat metastatic castration-sensitive prostate cancer (CSPC). The Johnson & Johnson (NYSE:JNJ) unit said regulatory applications seeking approval of the second-generation androgen receptor antagonist in the indication are expected this year.

On TITAN's primary endpoints, once-daily 240 mg oral Erleada plus androgen deprivation therapy significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) vs. placebo plus androgen deprivation therapy. The data will be submitted for presentation at a medical meeting...