J&J Sets Erleada On Real-Time Pathway For Castration-Sensitive Prostate Cancer Claim

Erleada is ninth product known to be using US FDA’s Real-Time Oncology Review pilot program, as shown in our comprehensive chart.   

Time-flies

Johnson & Johnson advanced its strategy of moving Erleada (apalutamide) into earlier stages of prostate cancer with a supplemental new drug application submission for treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) announced on 29 April 2019.

The company is hoping for approval “as soon as possible” thanks to the US Food and Drug Administration’s Real-Time Oncology Review (RTOR) pilot program

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