FDA grants traditional approval for pembrolizumab and Keytruda QLEX for TMB-H solid tumors
On October 16, 2026 the FDA granted traditional approval to pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmh (Keytruda QLEX) for patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors defined as ≥13 mutations/megabase. In the KEYNOTE-158 study, 220 patients with TMB ≥13 mut/Mb had an objective response rate of 36% (95% CI: 30, 43) and 58% achieved a duration of response of at least 12 months.
Primary source
FDA approval notification, October 22, 2026
FDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication
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