The swift US approval of Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc.'s Erleada (apalutamide) for treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) suggests that FDA had few concerns with the pivotal trial's novel primary endpoint.
Metastasis-Free Survival Endpoint Spreads To Labeling With US FDA Approval Of J&J's Erleada
Apalutamide, the first drug approved to treat non-metastatic castration-resistant prostate cancer, will also be the first NDA to have clinical summary report information made public under an FDA pilot program to increase transparency.
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