The FDA granted a supplemental efficacy approval for Keytruda (pembrolizumab) on February 15, 2019. This approval, designated as BLA 125514 S-40, was based on new efficacy data submitted by sponsor Merck Sharp Dohme.
Background
Keytruda (pembrolizumab) is a therapeutic agent developed by Merck Sharp Dohme. This specific supplemental application for BLA 125514 S-40 focused on demonstrating additional efficacy, leading to its approval by the FDA.
What this means
The FDA's supplemental efficacy approval for Keytruda (pembrolizumab) on February 15, 2019, indicates that new clinical data supported an expansion or modification of its approved uses based on demonstrated effectiveness. Supplemental applications are common for established drugs like pembrolizumab, allowing manufacturers to update labels with new indications, patient populations, dosing regimens, or other efficacy-related information without requiring a completely new drug application. This process ensures that the drug's prescribing information remains current with the latest clinical evidence, broadening its therapeutic utility for healthcare providers and patients.
Source
The information regarding this supplemental approval was sourced from the U.S. Food and Drug Administration (FDA) website. The approval for BLA 125514 S-40 was documented on February 15, 2019, on accessdata.fda.gov.