The U.S. Food and Drug Administration (FDA) approved a supplemental application for Keytruda (pembrolizumab) on April 28, 2020. This approval was granted based on efficacy data, as indicated by the supplemental Biologics License Application (BLA 125514 S-64) submitted by Merck Sharp Dohme.
What this means
This supplemental approval for Keytruda (pembrolizumab) signifies that the FDA has reviewed and accepted new clinical evidence supporting an expanded use for the drug. While the specific new indication or patient population is not detailed in the provided information, such efficacy-based approvals typically broaden the therapeutic options available to clinicians and patients, reflecting a positive assessment of the drug's benefits in an additional context.
Source
The information for this approval was sourced from the U.S. Food and Drug Administration (FDA). Details regarding the supplemental Biologics License Application (BLA 125514 S-64) for Keytruda (pembrolizumab) were made available on April 28, 2020, on the accessdata.fda.gov website.