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Can you recall the initial cancer indication for keytruda's fda approval?

See the DrugPatentWatch profile for keytruda

What was Keytruda’s first FDA-approved cancer indication?

Pembrolizumab (Keytruda) received its initial FDA approval for unresectable or metastatic melanoma that had progressed after treatment with ipilimumab and, if applicable, a BRAF inhibitor. [1]

When did that initial approval happen?

The first FDA approval for pembrolizumab (Keytruda) was in September 2014. [1]

How this relates to later indications

Subsequent FDA approvals expanded Keytruda to additional cancers and, in some settings, added companion-diagnostic requirements (for example, for PD-L1 status in certain indications). Those changes came after the original melanoma approval. [1]

Sources:
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125514s119lbl.pdf



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