Posted by Michael Wonder on 27 Jun 2018
Metastasis-free survival — a new end point in prostate cancer trials
27 June 2018 - Earlier this year, the FDA approved apalutamide, an androgen receptor inhibitor, for treatment of patients with non-metastatic castration-resistant prostate cancer.
The approval was based on SPARTAN, a randomised, placebo-controlled trial involving 1207 patients that demonstrated a statistically significant improvement in metastasis-free survival, defined as the time from randomisation to either imaging-detectable distant disease or death.
It was the first drug approval for non-metastatic castration-resistant prostate cancer and the first use of metastasis-free survival as a primary end point to support drug approval.
