IQVIA艾昆纬：2024年伴随诊断：医疗技术创新者的监管策略报告（英文版）

In November 2023, the FDA approved PD-L1 IHC 22C3 pharmDx, an assay used to assess PD-L1 expression. The diagnostic assay helps identify patients most likely to benefit from pembrolizumab (KEYTRUDA), a cancer immunotherapy designed for patients with high levels of PD-L1. Without the companion diagnostic (CDx), oncologists would have to rely on less accurate methods to determine which medication to prescribe, perhaps to the detriment of patient outcomes. Immunotherapies and other personalized