On December 18, 2015, the FDA approved a supplemental application for Keytruda (pembrolizumab), a significant regulatory action specifically related to its efficacy. This approval, identified as BLA 125514 S-6, was granted to sponsor Merck Sharp Dohme and expands the established uses of the drug based on new efficacy data.
Background
Pembrolizumab, marketed as Keytruda, is a prominent immunotherapy agent. Prior to this supplemental approval, pembrolizumab had already received initial FDA approvals. This particular supplemental application focused on providing additional evidence of the drug's efficacy, leading to an expansion or modification of its previously approved indications.
What this means
This supplemental approval for Keytruda (pembrolizumab), classified under 'Efficacy,' indicates that the FDA has reviewed and accepted new clinical data supporting the drug's effectiveness for an expanded or modified use. Supplemental applications are typically submitted when a sponsor seeks to add a new indication, a new patient population, a new dosing regimen, or a new route of administration, all based on demonstrated efficacy. While the specific details of the expanded indication are not provided in the summary data, this approval means that clinicians now have official FDA endorsement for using pembrolizumab in a broader context than its previous approvals, based on compelling evidence of its therapeutic benefits.
Source
The information regarding this approval was sourced from the FDA's website, specifically the overview for BLA 125514, on December 18, 2015. The document is titled 'FDA approved supplemental application for Keytruda (pembrolizumab) — Efficacy (BLA 125514 S-6)' and is available on accessdata.fda.gov.