On October 30, 2018, the U.S. Food and Drug Administration (FDA) approved a supplemental application for Keytruda (pembrolizumab). This approval pertains to an efficacy update for the immunotherapy drug.
Background
Keytruda (pembrolizumab) is a well-established programmed death receptor-1 (PD-1) blocking antibody, widely utilized in oncology for various cancer indications. This supplemental approval signifies an update to its efficacy profile, building upon its existing approvals.
What this means
This supplemental approval for Keytruda (pembrolizumab) indicates that the drug's label has been updated based on new clinical data supporting its effectiveness. While the specific details of the updated indication or patient population are not provided in the approval summary, such updates typically reflect new evidence of efficacy in an existing or expanded therapeutic context. This allows clinicians to consider the most current efficacy information when making treatment decisions for patients eligible for Keytruda therapy.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA). The approval for supplemental application BLA125514 S-41 for Keytruda (pembrolizumab) was posted on October 30, 2018, on accessdata.fda.gov.