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Keytruda (pembrolizumab) received its original FDA approval for the treatment of unresectable or metastatic melanoma. [1]
The initial approval focused on patients with melanoma whose tumors expressed the BRAF V600E mutation and had received prior therapy, aligning with the early melanoma treatment setting at the time of FDA review. [1]
The first FDA approval for Keytruda was in 2014. [1]
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514s000lbl.pdf
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