global
Variables
Utilities
CUSTOM STYLES

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

June 18, 2020

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.Click here to read the full press release.

This is some text inside of a div block.

Lung cancer questions? Contact our free HelpLine at support@go2.org or 1-800-298-2436.