New FDA review system used for Erleada submission
Johnson & Johnson (NYSE: JNJ) has announced it is seeking to broaden the label for Erleada (apalutamide) in the USA, to include treatment of people with metastatic castration-sensitive prostate cancer (mCSPC).
The bid is supported by data from the Phase III TITAN study, which compared Erleada plus androgen deprivation therapy (ADT) with placebo plus ADT.
The trial’s dual primary endpoints, overall survival (OS) and radiographic progression-free survival (rPFS), were both achieved.
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