The U.S. Food and Drug Administration (FDA) granted a supplemental approval for Keytruda (pembrolizumab) on June 12, 2018. This approval was for an efficacy supplement, indicating an expansion or modification of the drug's approved uses based on new efficacy data. The sponsor for this application was Merck Sharp Dohme.
What this means
This supplemental approval for Keytruda (pembrolizumab) signifies that the FDA has reviewed and accepted new data demonstrating the drug's efficacy for an additional or expanded indication. While the specific details of this new indication are not provided in the available information, such approvals typically broaden the patient population eligible for treatment or offer a new therapeutic option for an existing condition. This type of approval is based on a rigorous evaluation of clinical trial data, confirming the drug's benefits for the newly approved use.
Source
The information regarding this supplemental approval for Keytruda (pembrolizumab) was obtained from the U.S. Food and Drug Administration (FDA). This supplemental efficacy application, identified as BLA 125514 S-34, was approved on June 12, 2018, and is publicly accessible via accessdata.fda.gov.