FDA approves use of enzalutamide (Xtandi) for nmCRPC

As we predicted just a couple of weeks ago, on Friday the US Food and Drug Administration (FDA) approved the use of enzalutamide (Xtandi) for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC), based on the results of the Phase III PROSPER trial, which were initially reported at the beginning of the year at the ASCO Genitourinary Cancers Symposium, and recently published by Hussain et al. in the New England Journal of Medicine.

This means that there are now two forms of therapy approved by the FDA for the treatment of nmCRPC: enzalutamide (Xtandi) and apalutamide (Erleada).

It is also worth noting that the Institute for Clinical and Economic Review (ICER) has just issued a draft of an “evidence report” on antiandrogenic treatment of nmCRPC. For those who are interested, ICER is soliciting comment on this draft report through August 9, 2018. Your sitemaster notes that he was consulted by ICER (but received no remuneration) for his input during the development of this report. The relevant ICER media announcement is also available on line.

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