KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Tumor mutational burden (TMB) is an assessment of the number of somatic mutations in a defined region of a tumor genome and varies according to tumor type as well as among patients. Tumors with high levels of TMB are more likely to produce tumor cell surface epitopes that act as neoantigens and induce an elevated antitumor immune response. TMB status may be determined using next-generation sequencing methods. TMB-H may be a predictive biomarker for response to ICI therapy in some patients with advanced solid tumor.1,2

For certain patients with unresectable or metastatic solid tumors:
- Oncologists: Request TMB testing to help inform treatment decisions and identify potential patient eligibility for KEYTRUDA® (pembrolizumab).
- Pathologists: If testing reveals TMB ≥10 mut/Mb, inform the oncologist of the indication for KEYTRUDA.
Tumor mutational burden can be tested using the F1CDx™ assay from Foundation Medicine or via next-generation sequencing panels from select commercial reference laboratories.