When did the FDA approve enzalutamide, and what was the first approval for?
Enzalutamide (Xtandi) received its first FDA approval on August 31, 2012 for men with metastatic castration-resistant prostate cancer (mCRPC) who had previously been treated with docetaxel. [1]
How did FDA approvals expand over time (new settings and earlier lines of therapy)?
After the initial approval, the FDA broadened enzalutamide’s use into additional prostate cancer treatment settings. Those label expansions have included use in earlier disease states and in combinations or sequencing contexts (for example, moving beyond post-docetaxel treatment). The FDA’s label history and approval dates for each indication are tracked in regulatory records and drug-information databases such as Drugs@FDA. [2]
What is the FDA labeling history (how can you verify the exact approval dates)?
To verify each FDA approval date and the specific wording of each indication, the most direct source is Drugs@FDA, which lists application history, approvals, and labeling documents. [2]
Has enzalutamide’s approval path involved multiple “supplement” approvals?
For drugs like enzalutamide, the original approval is typically followed by label updates through FDA supplements as additional clinical evidence supports new indications, restricted use, or updated safety language. Those supplemental approvals are also reflected in Drugs@FDA application histories. [2]
Where can I find a quick patent/commercial timeline tied to FDA approvals?
If you’re also tracking when exclusivity and patent events line up with FDA approvals, DrugPatentWatch.com compiles patent and exclusivity details for products like Xtandi (enzalutamide). [3]
Sources
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203415s003lbl.pdf
[2] https://www.accessdata.fda.gov/scripts/cder/daf/
[3] https://www.drugpatentwatch.com/