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Which cancer type did keytruda first gain fda approval in?

See the DrugPatentWatch profile for keytruda

Which cancer did Keytruda get its first FDA approval for?

Keytruda (pembrolizumab) first gained FDA approval for advanced melanoma. Specifically, the FDA approved it for the treatment of patients with unresectable or metastatic melanoma that had progressed after ipilimumab (Yervoy) or, if they had a BRAF V600 mutation, after a BRAF inhibitor and ipilimumab [1].

What was Keytruda’s initial approval year and label wording?

The initial FDA approval for this melanoma indication occurred in 2014, under a label focused on patients whose disease had progressed following prior therapies as described in the approval language [1].

Did Keytruda’s first approval cover other cancers too?

No. The first FDA approval was for advanced melanoma with progression after prior treatment (including ipilimumab, and—when applicable—prior BRAF inhibitor therapy) [1].

Source

  1. https://www.fda.gov/drugs/resources-information-approved-drugs/pembrolizumab-keytruda


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