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FDA Approves Pembrolizumab in Metastatic TMB-H Solid Tumors
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Fusion42 · 23 October 2026 · Fusion42 review
The FDA converted pembrolizumab's accelerated approval to traditional approval for treating unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors with at least 13 mutations per megabase, based on phase 2 KEYNOTE-158 trial data showing significant durable responses.
This Wire brief sits within Fusion42's coverage of Drug Discovery.
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You must update your clinical development or commercial strategy if working on TMB-H solid tumor treatments as pembrolizumab's new approval defines a clearer biomarker cutoff that will set competitive standards and regulatory expectations.
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1 source · 22 Oct 2026
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