The U.S. Food and Drug Administration (FDA) approved a supplemental application for Keytruda (pembrolizumab) on June 7, 2024. This approval, designated as an efficacy update, was granted to sponsor Merck Sharp Dohme.
Background
Pembrolizumab (Keytruda) is an established immunotherapy. This supplemental approval pertains to an efficacy update, as indicated by the FDA, for which Merck Sharp Dohme is the sponsor.
What this means
The FDA's approval of a supplemental efficacy application for Keytruda (pembrolizumab) indicates an update or expansion of the drug's demonstrated effectiveness. While specific details of the updated efficacy are not provided in this announcement, such approvals typically reflect new data supporting the drug's use in an existing indication, a new patient population, or a refinement of its benefit-risk profile. Clinicians should consult the updated prescribing information for the full scope of this efficacy approval.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA). The approval for BLA 125514 S-154, an efficacy supplemental application for Keytruda (pembrolizumab), was recorded on June 7, 2024, on accessdata.fda.gov.