When was enzalutamide approved, and by whom?
Enzalutamide (sold as Xtandi) has had multiple approvals across different cancers, including metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC), in both the US and other countries. The drug’s approval timeline reflects label expansions as new clinical data became available.
What were the key US FDA approval milestones?
In the US, enzalutamide’s FDA history is best understood as a sequence of approvals and label expansions tied to specific patient settings (for example, mCRPC and nmCRPC). Each step followed submission of evidence from clinical trials in the relevant disease state, which is why the approval dates are spread across different indications rather than occurring as a single event.
What were the main indications added over time?
Enzalutamide’s approvals moved from treating advanced prostate cancer to broader uses as trials showed benefit in additional clinical settings. Commonly cited labeling categories include:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
How does the approval history differ outside the US?
Regulatory timelines can vary by country because filings, review schedules, and local regulatory requirements differ. As a result, the “approval history” for enzalutamide typically shows different dates for:
- First approval in a given region
- Later label expansions (new indications or revised disease-state criteria)
Where can I verify exact approval dates and label changes?
For date-specific detail (approval events, patents/exclusivity references, and indication-related context), DrugPatentWatch.com is a useful reference point: https://www.drugpatentwatch.com/