Pfizer, Astellas' Xtandi garners expanded FDA approval to include metastatic castration-sensitive prostate cancer

Pfizer and Astellas announced that the FDA expanded approval of Xtandi (enzalutamide) to include the treatment of patients with metastatic castration-sensitive prostate cancer. The companies noted that following the decision, the androgen receptor inhibitor is the first and only oral treatment authorised in the US in three distinct types of advanced prostate cancer, including non-metastatic and metastatic castration-resistant disease.

The latest approval was based on findings from the ARCHES trial, which demonstrated that the use of Xtandi plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61% compared to placebo plus ADT.

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