The U.S. Food and Drug Administration (FDA) granted a supplemental approval for Keytruda (pembrolizumab) on October 24, 2016. This approval, designated as BLA 125514 S-12, was specifically for efficacy, indicating an expansion of the drug's approved uses.
Background
Pembrolizumab, known by its brand name Keytruda, is a prescription medication developed by Merck Sharp Dohme. This supplemental approval for efficacy signifies that the FDA has reviewed additional data supporting the drug's effectiveness for new or expanded therapeutic applications, building upon its existing regulatory profile.
What this means
The FDA's supplemental efficacy approval for Keytruda (pembrolizumab) on October 24, 2016, represents a significant regulatory milestone. This decision allows clinicians to utilize Keytruda in a broader context, based on the demonstrated efficacy in the new application. For patients, it potentially expands access to this treatment option for additional conditions or populations where its benefits have been established.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA). The efficacy approval (BLA 125514 S-12) for Keytruda (pembrolizumab) was documented on October 24, 2016, and is publicly accessible via accessdata.fda.gov.