Janssen Receives FDA Approval for Prostate Cancer Drug

Janssen’s Erleada (apalutamide) earned FDA approval for treating patients with metastatic castration-sensitive prostate cancer (mCSPC).

Erleada is an oral androgen receptor inhibitor currently approved for non-metastatic castration-sensitive prostate cancer (nmCSPC). The agency first approved the drug for nmCSPC in February 2018.

The approval was granted based on the results of a phase 3 study in 1,052 patients of mCSPC in 23 countries, which showed that the drug improved overall survival and radiographic progression-free survival in patients.