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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
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unresectable or metastatic melanoma