The FDA granted a supplemental approval for Keytruda (pembrolizumab) on 2023-10-31. This approval, classified for efficacy, was issued to sponsor MERCK SHARP DOHME.
Background
Pembrolizumab, marketed as Keytruda, is an established immunotherapy. A supplemental efficacy approval from the FDA typically signifies an expansion of the drug's approved uses, such as a new indication or patient population, based on additional clinical data demonstrating its effectiveness.
What this means
This supplemental approval reinforces the demonstrated efficacy of pembrolizumab for an additional or modified use. While specific details of the new indication or patient population are not provided in this record, the approval confirms the FDA's assessment of its effectiveness for this expanded scope.
Source
The information regarding this supplemental approval was obtained from the FDA's Center for Drug Evaluation and Research (CDER) database. The approval for BLA 125514 S-144 was recorded on 2023-10-31 on accessdata.fda.gov.