The U.S. Food and Drug Administration (FDA) has approved Foundation Medicine's FoundationOne CDx for patients with solid tumors and high tumor mutational burden (TMB) who are eligible to take the immunotherapy pembrolizumab (Keytruda).
The FDA's approval covers use in high TMB patients who progressed after prior treatment and who have no satisfactory alternative treatment options. High TMB is defined as greater than or equal to 10 mutations/megabase (mut/Mb).
Keytruda is an inhibitor of programmed cell death ligand 1 (PD-L1) manufactured by Merck and was previously approved across solid tumor types with high microsatellite instability. The latest approval is the first TMB-specific indication granted to a checkpoint immunotherapy.
Foundation Medicine's FoundationOne CDx is a comprehensive genomic profiling companion test. It is approved for use in guiding treatment with more than 20 therapies across multiple cancer types.