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See the DrugPatentWatch profile for keytruda
Keytruda’s initial FDA clearance was for unresectable or metastatic melanoma. The FDA approval was specifically for patients with melanoma that had progressed after ipilimumab (Yervoy) and, if they had a BRAF V600 mutation, after a BRAF inhibitor. [1]
It was first approved for melanoma rather than a different solid tumor indication. Later approvals expanded Keytruda to additional cancers and combination regimens, but the first FDA indication was melanoma with prior-treatment requirements. [1]
The original indication wording and approval context are listed in the FDA approval record for Keytruda’s first approval. [1] Sources: [1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514
Other Questions About Keytruda :
unresectable or metastatic melanoma