The FDA approved a supplemental application for Keytruda (pembrolizumab) on June 19, 2018. This approval, designated BLA 125514 S-43, was granted based on efficacy data. The application was sponsored by Merck Sharp Dohme.
Background
Pembrolizumab, marketed as Keytruda, is a prescription medication that has received multiple prior approvals. This specific supplemental approval pertains to its efficacy, as indicated in the FDA's documentation. The sponsor for this application was Merck Sharp Dohme.
What this means
The supplemental FDA approval for Keytruda (pembrolizumab) on June 19, 2018, signifies an expansion of the drug's approved uses or patient population based on new efficacy data. While the specific details of the new indication are not provided in this regulatory summary, such approvals typically allow clinicians to prescribe the drug for additional conditions or in different treatment settings where its efficacy has been demonstrated. This expands the potential impact of pembrolizumab for patients, offering new treatment options where its benefits have been formally recognized by the FDA.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) website. The approval for BLA 125514 S-43, an efficacy supplement for Keytruda (pembrolizumab), was documented on June 19, 2018, on accessdata.fda.gov.