Tumor Mutational Burden as Pembrolizumab Predictor
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
TMB-High Indication Approval
- February 25, 2022
On February 25, 2022, Merck (MSD) announced Japanese regulatory approval expanding pembrolizumab indication to include TMB-high (high tumor mutational burden) advanced solid tumors after chemotherapy failure, where standard treatment is limited.
Clinical Significance
TMB-high status serves as predictive biomarker for anti-PD-1 immunotherapy response. This approval represents biomarker-driven therapeutic approach, enabling treatment of chemotherapy-refractory tumors across cancer types based on mutational burden assessment.
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