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Home » Janssen Receives FDA Approval for Prostate Cancer Drug

Janssen Receives FDA Approval for Prostate Cancer Drug

September 26, 2019

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.

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