FDA approves pembrolizumab for adults and children with TMB-H solid tumors

[Miranda_GO2]

On June 16th, 2020, the Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) for treatment of all advanced, metastatic cancers with a tumor mutational burden-high (TMB-H) designation. The FDA based their approval on the results of the clinical trial KEYNOTE-158 which showed that a high percentage of patients receiving Keytruda experienced a response to the treatment. In addition, the response lasted for a significant amount of time.

The new labeling approval for Keytruda gives a new subset of patients access to the drug that may not have previously qualified for it without additional chemotherapy. The FDA has also approved the Foundation One CDx assay as a companion diagnostic for Keytruda.

Here's the full press release:fda.gov/drugs/drug-approval...