FDA updates pembrolizumab’s tumor-mutation indication with traditional approval
FDA reports traditional approval for pembrolizumab products for specified previously treated advanced solid tumors, with a revised tumor-mutation threshold.
What the record says
The October 22 notice describes an October 16 decision covering unresectable or metastatic TMB-high solid tumors after prior treatment when satisfactory alternatives are unavailable. The updated indication uses at least 13 mutations per megabase on an FDA-authorized test, replacing the earlier threshold of 10. FDA says confirmatory efficacy was not established in the 10-to-under-13 group.
Source details and supporting locations.
Practical next step
Patients should discuss treatment questions with their oncology team; clinicians should consult current prescribing information.
Limits and what is not established
This is a regulatory report, not an individual treatment recommendation. Eligibility and safety depend on the full approved labeling.
Sources checked October 25, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information