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Xtandi FDA Approval History

Last updated by Judith Stewart, BPharm on May 4, 2021.

FDA Approved: Yes (First approved August 31, 2012)
Brand name: Xtandi
Generic name: enzalutamide
Dosage form: Capsules and Tablets
Company: Astellas Pharma US, Inc.
Treatment for: Prostate Cancer

Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer.

Development timeline for Xtandi

Mar 17, 2023Phase 3 Study Shows XTANDI plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer
Oct 18, 2022Lack of global regulatory coordination for cancer clinical trials costs 1.5 million lives a year despite therapies being available
Dec 16, 2019Approval FDA Approves Xtandi (enzalutamide) for the Treatment of Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Jul 13, 2018Approval FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
Aug 31, 2012Approval FDA Approves Xtandi for Late-Stage Castration-Resistant Prostate Cancer
May 22, 2012Medivation and Astellas Announce Submission of New Drug Application for Enzalutamide for the Treatment of Castration-Resistant Prostate Cancer in Patients Previously Treated with Chemotherapy

Further information

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