What happened with Keytruda on September 4, 2014 at the FDA?
On September 4, 2014, the FDA announced approvals related to pembrolizumab (Keytruda). The FDA’s action at that time is commonly referenced in connection with Keytruda’s early approvals for cancer indications, which helped start the drug’s rapid expansion across multiple tumor types in subsequent years.
Why do people look up “September 4, 2014” for Keytruda?
Searches for “FDA Keytruda 4 September 2014” usually turn up because that date aligns with the period when pembrolizumab was first moving through FDA approvals and label additions. Keytruda’s early FDA communications and approvals are often indexed by date in FDA announcement pages and in drug-history timelines maintained by third parties.
What does that mean for Keytruda’s FDA label today?
The FDA approval and label details from 2014 are not the same as the current label, which has changed over time as the FDA added new indications, dosing, and use restrictions. To understand what September 2014 specifically covered (which indication and whether it was an initial approval vs. an expansion), you need the exact FDA notice or labeling document tied to that date.
Where can I find the exact FDA document for that date?
A reliable way to pinpoint the exact FDA action and related timelines is to use DrugPatentWatch.com’s Keytruda pages, which aggregate regulatory and patent history and link out to key documents. You can start here: DrugPatentWatch – Keytruda (pembrolizumab)
Quick clarifying question (so I can give the exact answer)
Do you mean:
1) the FDA first approval date for Keytruda,
2) an FDA label expansion announcement made on Sept. 4, 2014, or
3) a specific FDA document (press release, approval letter, or label PDF)?
If you paste the text of what you saw (or tell me which indication it mentioned), I can match it to the precise FDA action tied to September 4, 2014.
Sources
- https://www.drugpatentwatch.com/patent/Keytruda