The U.S. Food and Drug Administration (FDA) approved a supplemental application for Keytruda (pembrolizumab) on 2017-05-10. This approval was specifically for efficacy, indicating an expansion of the drug's approved uses or patient population.
Background
Keytruda (pembrolizumab) is an established pharmaceutical product. This supplemental application was sponsored by Merck Sharp Dohme and pertained to the drug's efficacy, suggesting new data supported its effectiveness for an additional use.
What this means
A supplemental efficacy approval for Keytruda (pembrolizumab) signifies that the FDA has reviewed and accepted new clinical or scientific data supporting the drug's effectiveness for an additional indication or patient population. Such an approval expands the therapeutic options available to healthcare providers, allowing them to prescribe pembrolizumab for a broader range of patients who may benefit from its mechanism of action. For patients and patient advocates, this represents increased access to an established treatment. Researchers may find this development relevant for understanding the evolving landscape of immunotherapies.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA) on 2017-05-10. Details of the approval, identified as supplemental application S-16 under Biologics License Application (BLA) BLA125514, are available on accessdata.fda.gov.