Wire · operational-macro
FDA Grants Full Approval to Pembrolizumab for Patients With Tumor Mutational Burden ...
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Fusion42 · 23 October 2026 · Fusion42 review
The FDA granted traditional approval to pembrolizumab for treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high solid tumors, raising the TMB threshold from 10 to 13 mutations per megabase based on the KEYNOTE-158 trial outcomes.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it between 22 Oct 2026 and 23 Oct 2026.
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The stricter tumor mutation burden threshold narrows eligible patients and shifts focus onto precise genetic testing for immunotherapy. You must adjust your patient selection and testing protocols to stay competitive and compliant.
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3 sources · first reported 22 Oct 2026 · latest 23 Oct 2026
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