Janssen announced that the European Commission has approved the expanded use of Erleada (apalutamide) in patients with metastatic hormone sensitive prostate cancer (mHSPC). The drug is indicated in combination with androgen deprivation therapy (ADT). The drug has been earlier approved for patients with non-metastatic castration-resistant prostate cancer.
The approval is based on the Phase 3 TITAN study. Apalutamide plus androgen deprivation therapy was compared with placebo plus androgen deprivation therapy. The primary endpoint is the overall survival and radiographic progression-free survival. There was a reduction in the risk of death by 33% in apalutamide group compared to placebo group. Median overall survival not reached in both the arms. The risk of radiographic progression or death was reduced by 52%, the median rPFS was 22.1 months for the placebo arm, whereas rPFS was not reached in the apalutamide arm.
The safety profile of the drug is similar to reports established in the earlier studies.
The drug is an androgen receptor inhibitor indicated for the treatment of non-metastatic castration-resistant prostate cancer in Europe. The drug has been approved for the metastatic hormone-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer.
About prostate cancer:
Prostate cancer is the cancer of the prostate gland involved in the production of seminal fluid. In metastatic hormone-sensitive prostate cancer, the patient responds to androgen deprivation therapy.