On October 14, 2020, the FDA approved a supplemental application for Keytruda (pembrolizumab), a decision based on new efficacy data. This approval, designated BLA 125514 S-85, was granted to sponsor Merck Sharp Dohme.
Background
Pembrolizumab (Keytruda) is an established therapeutic agent. This supplemental approval indicates an expansion of its approved uses or an update to its efficacy profile, as determined by the FDA's review of additional data.
What this means
This supplemental approval for Keytruda (pembrolizumab) signifies that the FDA has reviewed and accepted additional efficacy data for the drug. While the specific indication or patient population for this supplemental approval is not detailed in the available information, such approvals typically expand the drug's label to include new uses, patient populations, or updated dosing regimens based on demonstrated efficacy. Clinicians should consult the updated prescribing information for full details on this expanded approval.
Source
The information regarding this supplemental approval was obtained from the FDA's official database. The approval for BLA 125514 S-85 for Keytruda (pembrolizumab) was recorded on October 14, 2020, on accessdata.fda.gov.