A supplemental application for Keytruda (pembrolizumab) received FDA approval on August 16, 2018. This approval, designated BLA 125514 S-46, was granted based on demonstrated efficacy.
What this means
This supplemental FDA approval for Keytruda (pembrolizumab) signifies an expansion of the drug's approved therapeutic applications. Supplemental approvals are granted when new data supports the drug's efficacy for an additional use, which can include a new indication, a different patient population, or an updated dosing regimen. This particular approval confirms an expansion based on new efficacy data, enhancing the drug's utility for clinicians and patients.
Source
The information regarding this supplemental FDA approval was obtained from the official FDA website. The approval for BLA 125514 S-46 was granted on August 16, 2018, and is publicly accessible via accessdata.fda.gov.