On June 17, 2019, the U.S. Food and Drug Administration (FDA) granted a supplemental approval for Keytruda (pembrolizumab). This approval was based on new efficacy data submitted by the sponsor, Merck Sharp Dohme, indicating an expansion of the drug's approved uses.
Background
Pembrolizumab, marketed as Keytruda, is a therapeutic drug developed by Merck Sharp Dohme. This supplemental application pertained to its efficacy, leading to an update in its approved uses.
What this means
The supplemental FDA approval for Keytruda (pembrolizumab) signifies that the agency has reviewed and accepted new clinical evidence demonstrating the drug's efficacy in an expanded context. While the specific new indication or patient population is not detailed in the provided information, such approvals typically broaden the therapeutic options available for patients, allowing Keytruda to be used for additional conditions or in different treatment settings.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) website. The approval for BLA 125514 S-53, an efficacy-based supplemental application, was posted on 2019-06-17 on accessdata.fda.gov.