I agree that you do need evidence or some reasoning for the criteria but that may not be 'clinical' in terms of a clinically validated assay. It could just be preclinical support for the association between the target and the disease. According to Jørgensen's report in JCO Precision Oncology (May 2022), the FDA was still waiting for the post-market IVD data for several approved indications of pembro:
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