How long did keytruda's fda approval process take?

How long did the FDA approval process take for Keytruda (pembrolizumab)?

Keytruda’s first FDA approval took about 4 months, from September 4, 2014 (FDA approval of pembrolizumab for advanced melanoma) to January 6, 2015. [1]

What dates are those, and what do they represent?

The FDA “approval” date is when the agency officially approves the drug for the first listed indication. The time between the submission milestone and the eventual approval is commonly discussed as the “approval process” duration; for Keytruda’s initial approval, the timeline above reflects the reported approval period tied to that first authorization. [1]

Did the approval timeline differ for later Keytruda indications?

Yes. Keytruda received multiple FDA approvals and label expansions after its initial approval, and each subsequent indication can have a different review timeline depending on the submission type and regulatory pathway. Those later approval intervals are separate from the initial approval process described above. [1]

Sources

[1] https://www.drugpatentwatch.com/patent/biopharmaceutical/pembrolizumab-keytruda