Janssen has announced that the FDA has expanded the label of its androgen receptor inhibitor Erleada (apalutamide) to include the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
The therapy was evaluated under Priority Review Designation through the US regulator’s Real-Time Oncology Review programme. It is estimated that around 40,000 new diagnoses of mCSPC are made in the US each year.
