When did keytruda initially gain fda's nod?

When did Keytruda first get FDA approval?

Keytruda (pembrolizumab) initially received FDA approval in 2014. The FDA’s first approval for Keytruda was on September 4, 2014 [1].

What was the first FDA indication for Keytruda?

Keytruda’s initial FDA nod in September 2014 was for the treatment of patients with unresectable or metastatic melanoma that had progressed after ipilimumab (or after anti–PD-1 therapy in later lines, depending on label updates) [1].

Did Keytruda’s FDA approval happen in multiple steps after 2014?

Yes. Keytruda received additional approvals and label expansions after its first FDA approval in 2014 as clinical trial results supported use in more cancers and combinations [1].

Sources:
1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514