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

The US Food and Drug Administration granted accelerated approval for an additional indication for Keytruda (pembrolizumab), Merck & Co’s (NYSE: MRK) best-selling drug with 2019 sales of $11.08 billion, and already approved for a number of cancer indications.

The latest approval is for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

The FDA also approved the FoundationOne CDx assay, from Foundation Medicine, as a companion diagnostic for pembrolizumab.