The U.S. Food and Drug Administration (FDA) approved a supplemental application for Keytruda (pembrolizumab) on 2021-12-03. This approval, designated BLA 125514 S-112, specifically pertains to an efficacy claim, as submitted by sponsor Merck Sharp Dohme.
Background
Pembrolizumab, known commercially as Keytruda, is a prominent therapeutic agent. This supplemental approval signifies an expansion of its demonstrated efficacy, indicating that the drug has met regulatory standards for an additional use. The sponsor for this application was Merck Sharp Dohme.
What this means
The FDA's approval of a supplemental application for efficacy for Keytruda (pembrolizumab) means that the drug's label has been updated to include a new indication or patient population where its benefits have been demonstrated. This type of approval is granted when clinical data supports a new use for an already approved medication. For clinicians, this expands the therapeutic options available for patients. Researchers and patient advocates will look to the updated prescribing information for specific details on the new approved use, which will guide further study and patient care decisions. The approval reflects a regulatory determination of the drug's positive benefit-risk profile for the newly approved indication.
Source
The official record of this supplemental approval was retrieved from the U.S. Food and Drug Administration (FDA) database. The approval, identified by BLA 125514 S-112 for Keytruda (pembrolizumab), was documented on 2021-12-03 and is accessible via accessdata.fda.gov.