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Keytruda Wins Full FDA Approval for High-Mutation Tumors, but a Stricter Cutoff Could ...
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Fusion42 · 25 October 2026 · Fusion42 review
The FDA granted full approval to Keytruda for advanced solid tumors with a high tumor mutational burden (TMB) at a stricter cutoff of 13 mutations per megabase, up from the previous threshold of 10. This change affects eligibility for treatment and insurance coverage, particularly for patients with tumors scoring between 10 and 12 mutations per megabase.
This Wire brief sits within Fusion42's coverage of Biotech.
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You must update patient eligibility criteria to the stricter FDA TMB cutoff of 13 mutations per megabase as insurers will likely restrict coverage below this. Clarify test details with oncologists to avoid access issues for patients scoring just below the new threshold.
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1 source · 25 Oct 2026
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