On October 16, 2026, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥13 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.