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FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer

The FDA has approved a supplemental New Drug Application (sNDA) for apalutamide (Erleada) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

The sNDA was processed through the Real-Time Oncology Review Program after the application received a priority review designation when it was submitted in April 2019. Results of the phase III TITAN trial, which were presented at the 2019 ASCO Annual Meeting, were the basis for the sNDA

Read the full article here.

source: Lisa Astor - Targeted Oncology