enzalutamide (Xtandi): FDA status

Approved Approved Feb 16, 2024. Indication: nonmetastatic castration sensitive prostate cancer with biochemical recurrence at high risk for metastasis. Company: Astellas/Pfizer.

Regulatory history

• Feb 16, 2024: Approved. FDA approved enzalutamide for nonmetastatic castration sensitive prostate cancer, discussed by Dr Shore. OncLive
• Nov 16, 2023: Label expanded. FDA approved enzalutamide for nonmetastatic castration sensitive prostate cancer with high risk biochemical recurrence, usable with or without a GnRH analog. renalandurologynews.com

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