On June 12, 2025, the FDA approved a supplemental application for Keytruda (pembrolizumab), expanding its demonstrated efficacy. This approval, designated BLA 125514 S-180, was granted to sponsor Merck Sharp Dohme.
Background
Keytruda (pembrolizumab) is an immunotherapy drug. This supplemental approval pertains to its efficacy, indicating an expansion of its therapeutic utility for which new data has been reviewed and accepted by the FDA.
What this means
This supplemental approval for Keytruda (pembrolizumab) signifies that the FDA has reviewed additional data supporting the drug's effectiveness. This expansion of efficacy may allow for broader use of pembrolizumab in clinical practice, providing clinicians with more options for patient treatment.
Source
The information regarding this supplemental FDA approval was obtained from the FDA's official database. The approval for BLA 125514 S-180 was posted on June 12, 2025, on accessdata.fda.gov.