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Xtandi FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 21, 2023.

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 used for the treatment of prostate cancer.

Development timeline for Xtandi

DateArticle
Jan 26, 2024Nanoform Announces Important Milestone with Promising Clinical Results for Patient-Centric Nanotechnology-Enhanced Enzalutamide
Nov 16, 2023Approval Pfizer and Astellas' Xtandi Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
Jun 20, 2023Approval Pfizer’s Talzenna (talazoparib) in Combination with Xtandi (enzalutamide) Receives U.S. FDA Approval for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
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

See also

Xtandi (enzalutamide) Consumer information

Further information

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