On August 20, 2018, the U.S. Food and Drug Administration (FDA) approved a supplemental application for Keytruda (pembrolizumab). This approval, designated as an efficacy supplement (BLA 125514 S-35), was granted to sponsor Merck Sharp Dohme.
What this means
This supplemental efficacy approval for Keytruda (pembrolizumab) by the FDA on August 20, 2018, signifies that new efficacy data has been reviewed and accepted by the agency. While the specific indication or patient population for this supplemental approval is not detailed in the provided information, such approvals typically expand the therapeutic scope of an already approved drug. This allows clinicians to potentially use pembrolizumab in a broader context, based on the newly recognized efficacy, following further guidance on the specific approved use.
Source
The information for this article is based on the official record of the U.S. Food and Drug Administration (FDA) for supplemental application BLA 125514 S-35. This record, documenting the efficacy approval for Keytruda (pembrolizumab), was updated on August 20, 2018, and is accessible via accessdata.fda.gov.