Xtandi wins US approval earlier in prostate cancer

17 November 2023

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Astellas (TYO: 4503) and Pfizer’s (NYSE: PFE) Xtandi (enzalutamide) has won a new approval in prostate cancer from the US Food and Drug Administration (FDA).

A supplemental New Drug Application for the androgen receptor signaling inhibitor has been approved, making it the only drug of its class to be approved for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).

"Previously, treatment options for these BCR patients, especially those who have a high likelihood of developing metastases were limited"

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