FDA approves J&J’s Erleada for mCSPC

Following FDA approval in 2018 of Erleada (apalutamide) for non-metastatic castration-resistant prostate cancer (nmCRPC), the FDA has now granted approval for Johnson & Johnson’s androgen inhibitor drug for metastatic castration-sensitive prostate cancer (mCSPC) on the back of positive results from the phase 3 TITAN study. The study involved 1,052 patients and compared Erleada to placebo given in addition to androgen-deprivation therapy. The study found that Erleada reduced the risk of death by 33% versus the control group. The two-year overall survival rates were 84% in the group of patients on Erleada and 78% in the control group.
mCSPC accounts for a sizeable number of prostate cancer patients with advanced disease but whose tumours still remain sensitive to treatment with ADT, and only between 10% and 20% of prostate cancer cases are castration-resistant.