On May 17, 2017, the FDA approved a supplemental application for Keytruda (pembrolizumab), indicating an expansion of its approved uses based on demonstrated efficacy. This approval was granted following a review of data supporting the drug's effectiveness.
What this means
The FDA's supplemental approval for Keytruda (pembrolizumab) on May 17, 2017, signifies an expansion of the drug's approved therapeutic applications. Supplemental approvals are granted when new clinical data demonstrate additional efficacy for a drug, allowing it to be used for a new patient population, a new disease indication, or in a new treatment setting. This specific approval, categorized under 'Efficacy,' confirms that the FDA has reviewed and accepted evidence supporting the drug's benefits for an expanded use. While the precise details of the new indication or patient population are not specified in the provided information, this type of regulatory action broadens the availability of Keytruda to more patients who may benefit from its therapeutic effects.
Source
The information regarding this supplemental approval was obtained from the U.S. Food and Drug Administration (FDA). The approval for supplemental application BLA 125514 S-13 was recorded on May 17, 2017, and is accessible via accessdata.fda.gov.