Posted by Michael Wonder on 12 Dec 2018
Metastasis-free survival in prostate cancer: faster drug approvals, better drugs?
12 December 2018 - On 13 February 2018, the US FDA granted marketing authorisation to apalutamide for treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).
Five months later, the FDA approved enzalutamide for the same indication. The FDA made these approvals on the basis of two randomised trials that showed improved metastasis-free survival when the active agent was compared with placebo.
There is a trade-off between speed and certainty in drug approvals of anti-neoplastic agents. Although overall survival (OS) is a clear and important measure of patient benefit, it takes time to demonstrate an OS effect, particularly as advances in standard-of-care therapy improve survival. This has been the case over the last decade with prostate cancer.
