FDA approves pembrolizumab for treatment of adult and paediatric patients with unresectable or metastatic tumour mutational burden-high (TMB-H) solid tumours determined through biomarker-based testing.

Approval was based on data from an analysis of 10 cohorts of patients who have various previously treated unresectable or metastatic solid tumours with TMB-H and had been enrolled in KEYNOTE-158 study.


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