medwireNews: Following a priority review, the androgen receptor inhibitor apalutamide has been approved by the US FDA for men with nonmetastatic castration-resistant prostate cancer (CRPC).
The decision is based on the SPARTAN trial, the results of which were reported at the 2018 ASCO Genitourinary Cancers Symposium in San Francisco, California, USA.
In the trial, metastasis-free survival was significantly longer for the patients who were randomly assigned to receive oral apalutamide 240 mg/day than for those who received placebo, where both were given alongside androgen deprivation therapy, with median times of 40.5 and 16.2 months, respectively.
Apalutamide is to be administered at the dose used in the trial, the FDA decision states.
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