The Food and Drug Administration (FDA) has approved an expanded indication for Xtandi (enzalutamide; Astellas Pharma) to include the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC), making it the first oral medication approved for both non-metastatic and metastatic CRPC.

The approval was based on data from the Phase 3 PROSPER trial which enrolled 1401 patients with non-metastatic CRPC. Patients were randomized to either Xtandi + androgen deprivation therapy (ADT) or placebo + ADT with the major efficacy endpoint being metastasis-free survival (MFS). Results showed that the use of Xtandi + ADT significantly reduced the risk of developing metastases or death vs ADT alone. MFS was found to be 36.6 months in patients who received Xtandi compared with 14.7 months in the placebo arm (hazard ratio [HR] 0.29; 95% CI, 0.24–0.35; <.0001). 

The primary efficacy outcome was supported by a statistically significant delay in time to first use of new antineoplastic therapy (TTA) for patients in the Xtandi arm vs the placebo arm. The median TTA was 39.6 months for Xtandi vs 17.7 months for placebo (HR 0.21; 95% CI, 0.17–0.26; <.0001).

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“With today’s approval, there is now a new option for men with non-metastatic CRPC, who are in between the failure of androgen deprivation therapy resulting in CRPC and the onset of metastatic disease,” said Jonathan Simons, MD, Prostate Cancer Foundation President and CEO. “As a foundation that drives research aimed at improving patient outcomes, it is exciting to see approvals like this, which are vital to help address unmet patient needs.” 

Xtandi, an androgen receptor inhibitor, is supplied as 40mg capsules in 120-count bottles. 

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