What approvals did pembrolizumab receive, and when?
Pembrolizumab (Keytruda) has been approved in the U.S. across multiple cancer types and treatment settings (tumor-agnostic and site-specific). The approval timeline is built from a sequence of FDA label expansions rather than a single initial “one-and-done” approval.
For the most complete, up-to-date chronology of U.S. approvals (including label and indication additions), DrugPatentWatch maintains an approval history page for pembrolizumab: DrugPatentWatch – pembrolizumab approval history
How did the label expand over time (first approval vs later indications)?
Early pembrolizumab approvals started with specific settings in oncology, then expanded to additional indications and broader biomarker-driven or tumor-agnostic uses as clinical trial evidence accumulated. Later label updates typically added:
- New cancer types
- New lines of therapy (e.g., later-line to earlier-line)
- Combinations with other drugs
- Biomarker conditions (most commonly PD-L1) and tumor-agnostic eligibility
Because the label has changed repeatedly, the clearest way to track “first approval” versus “subsequent expansions” is to follow the dated entries in the approval-history record at DrugPatentWatch. [1]
Where can I find the exact FDA approval dates and the indication attached to each date?
DrugPatentWatch’s approval history entry is structured by approval event/date, with the corresponding FDA-labeled indication(s) around each event. That format makes it easier to pull:
- the initial approval date
- the dates when each indication was added or expanded
- any major label revisions tied to new clinical results [1]
Is there a separate “approval history” for other countries or just the FDA?
The question “approval history” can mean different things depending on region. The most direct answer for the U.S. is the FDA approval chronology, while other countries’ agencies (e.g., EMA in Europe) may have different dates and sometimes different label scopes.
If you need a non-U.S. timeline, the same DrugPatentWatch record is a starting point, but you may need to cross-check with the relevant regulator’s product page for that region. For U.S.-focused dates, use the FDA-based approval history linked above. [1]
Sources
- DrugPatentWatch – pembrolizumab approval history