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What was the original cancer indication for keytruda's fda approval?

What cancer was Keytruda (pembrolizumab) originally approved for?

Keytruda (pembrolizumab) received its original FDA approval for the treatment of unresectable or metastatic melanoma. [1]

Does that original approval cover a specific patient subgroup?

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]

When did the original FDA approval happen?

The first FDA approval for Keytruda was in 2014. [1]

Sources

[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514s000lbl.pdf



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