Merck’s Keytruda Grabs Second Biomarker-Based Indication

The FDA has granted accelerated approval to Merck’s Keytruda (pembrolizumab) as a monotherapy for patients with unresectable or metastatic tumor mutational burden-high solid tumors.

The approval was the second based on the use of specific mutations as biomarkers rather than on the tumor’s original location in the body.

The agency has also approved the FoundationOne CDx test as a companion diagnostic to identify patients who may benefit from treatment with Keytruda.