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What was keytruda's initial fda approved indication?

See the DrugPatentWatch profile for keytruda

What indication did Keytruda get first approved for by the FDA?

Keytruda (pembrolizumab) received its first FDA approval for the treatment of unresectable or metastatic melanoma—specifically patients with disease progression following ipilimumab (or after ipilimumab and, if appropriate, a BRAF inhibitor), and for whom there was no satisfactory alternative treatment available [1].

When was that first approval granted?

That initial FDA approval is listed as September 4, 2014 [1].

How to read “initial indication” versus later expansions

FDA approval labels can later expand to include additional cancers and line-of-therapy changes. The “initial indication” refers to the first condition the FDA allowed pembrolizumab to treat when it launched, before subsequent updates to the prescribing information [1].

Sources:
[1] https://www.drugpatentwatch.com/p/keytruda/



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