What was Keytruda’s FDA approval timeline for cancer?
Keytruda (pembrolizumab) has received multiple FDA approvals over time, with the earliest approvals starting in 2014. The specific approval timeline depends on the cancer type and the indication.
From the FDA drug label history, Keytruda’s major approval milestones include:
- 2014 (initial approvals): The FDA granted early approvals for Keytruda starting in 2014 [1].
- 2015–2017 (expanding indications): FDA approvals continued across multiple cancers in the mid-to-late 2010s, reflecting expansion of use beyond the original settings [1][2].
- 2018 (notable expansion year): The label history shows additional FDA approvals added in 2018 [2].
- 2019–2021 (further label expansions): FDA approvals continued through this period, including new cancer contexts and combinations [2].
- 2022–2023 (continued updates): More FDA approval entries appear in the 2022 and 2023 label history [2].
- 2024 (ongoing updates): The label history includes FDA approval activity in 2024 as well [2].
Which cancer indications does the timeline cover?
Keytruda’s FDA approvals are not for one single “cancer” but for specific diseases and settings (such as particular tumor types, stages, line of therapy, and whether it is used alone or with other treatments). The FDA label history provides the overall sequence of approvals, while the label’s indication sections specify the cancer types tied to those approvals [1][2].
How can I get the exact approval dates for my specific cancer type?
If you tell me the cancer type you care about (for example, melanoma, lung cancer, head and neck cancer, urothelial cancer, breast cancer, colorectal cancer, lymphoma, etc.), I can map the timeline to the specific FDA approval entry for that indication.
To do this precisely, it helps to use the FDA’s Current/Original label and the FDA label approval history sections referenced by the label history sources [1][2].
Are there different “approval dates” depending on the document?
Yes. Users often see multiple dates for the same product because FDA materials can be updated for different label actions (new indication approvals, supplements, revisions). The label history pages track FDA actions over time, but each action may correspond to a different approval supplement rather than a single “first approval” date [1][2].
Sources used (FDA label history)
- Keytruda (pembrolizumab) FDA label history and approvals – Drugs@FDA
- Keytruda FDA prescribing information and FDA label history (approval supplements/updates)