The U.S. Food and Drug Administration (FDA) approved a supplemental application for Keytruda (pembrolizumab) on June 24, 2020. This approval, designated BLA 125514 S-68, was granted based on efficacy data submitted by the sponsor, MERCK SHARP DOHME.
Background
Pembrolizumab, marketed as Keytruda, is an established immunotherapy. This supplemental approval indicates an expansion or modification of its approved uses, specifically pertaining to its efficacy profile, as determined by the FDA.
What this means
The FDA's supplemental approval for Keytruda (pembrolizumab) based on efficacy data signifies an update to the drug's approved therapeutic scope. While the specific details of the new indication or patient population are not provided in the source, this type of approval typically allows for new or expanded claims regarding the drug's effectiveness in treating a particular condition or in a specific patient group. Clinicians and researchers will refer to the full label update for precise details on the expanded use.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) website on June 24, 2020. The details are available under BLA 125514 on accessdata.fda.gov.