Table 1.
Results of the systematic database retrieval in PharmNet CT. Displayed are the medicinal product–biomarker combinations with ≥30 search results, based on the search query category “Medicinal Product AND Biomarker”. Included are clinical trials conducted in the EU from 2004–2022. Results are compared to medicinal products and associated biomarkers in alignment with IVD approved as CDx by non-European national authorities.
| Medicinal Product | Biomarker | Number of Search Results | IVD Approved as CDx (National Authority) |
|---|---|---|---|
| Pembrolizumab | PD-L1 | 171 | FDA, PMDA |
| Nivolumab | PD-L1 | 92 | FDA |
| Rituximab | CD20 | 89 | - |
| Trastuzumab | HER2 | 85 | FDA, HCSC |
| Atezolizumab | PD-L1 | 76 | FDA, PMDA |
| Durvalumab | PD-L1 | 54 | - |
| Cetuximab | EGFR | 48 | FDA, HCSC |
| Ipilimumab | PD-L1 | 41 | FDA * |
| Erlotinib | EGFR | 41 | FDA, HCSC, PMDA |
| Pembrolizumab | EGFR | 39 | - |
| Pertuzumab | HER2 | 33 | FDA, HCSC |
| Ivacaftor | CFTR | 32 | - |
| Pembrolizumab | ALK | 32 | - |
FDA = Food and Drug Administration (USA), HCSC = Health Canada/Santé Canada (Canada), PMDA = Pharmaceuticals and Medical Devices Agency (Japan). * CDx approval for a combination therapy of nivolumab and ipilimumab.