FDA approves pembrolizumab or Keytruda Qlex for TMB-H solid tumors
On October 16, 2026, the FDA 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) solid tumors defined as ≥13 mutations/megabase. The approval converts the prior accelerated approval and amends the TMB-H definition to ≥13 mut/Mb, as efficacy was not confirmed in patients with TMB of 10 to <13 mut/Mb.
Primary source
FDA approval notification, November 6, 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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