Janssen Seeks Expanded FDA Approval of Erleada to Treat Metastatic Castration-sensitive Prostate Cancer

Janssen Seeks Expanded FDA Approval of Erleada to Treat Metastatic Castration-sensitive Prostate Cancer
Janssen has submitted an application with the U.S. Food and Drug Administration (FDA) seeking the approval of its androgen receptor inhibitor Erleada (apalutamide) for patients with metastatic castration-sensitive prostate cancer (CSPC). The supplemental new drug application is based on data from the ongoing Phase 3 TITAN clinical trial (NCT02489318), which showed that adding Erleada to first-line androgen deprivation therapy (ADT) extended survival and delayed disease progression or death in these patients. It is being reviewed under the FDA’s Real-Time Oncology Review program, a pilot program that allows the FDA to start reviewing clinical data before an official application is submitted. The new program is intended to accelerate the review process so that treatments are available for patients as soon as possible. “This submission marks an important step in providing a potential treatment option for patients with metastatic castration-sensitive pros
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