Table 2.
Active substances acquired from an additional PharmNet CT database readout, resulting from search query category “Biomarker AND Detection Method”. Listed are only active substances of targeted therapies with related biomarkers and the approved indication. Further information on available companion diagnostic tests is added.
| Active Substance | Related Biomarkers | CDx [Yes/No] (FDA/PMDA/HCSC) |
Approved Indication |
|---|---|---|---|
| Trastuzumab | HER2 (ERBB2) Hormone receptor |
Yes (FDA, PMDA, HCSC) No |
Stomach neoplasms, breast neoplasms [18] |
| Pembrolizumab | ALK BRAF EGFR MMR MSI PD-L1 TMB |
No No No No Yes (PMDA) Yes (FDA, PMDA) Yes (FDA) |
NSCLC, melanoma, renal cell carcinoma, Hodgkin lymphoma, urologic/endometrial neoplasms, squamous cell carcinoma [19] |
| Atezolizumab | ALK BRAF EGFR PD-L1 |
No No No Yes (FDA, PMDA) |
NSCLC, small cell lung carcinoma, breast- and urologic neoplasms [20] |
| Entrectinib | ROS1 NTRK |
Yes (PMDA) Yes (PMDA) |
Various cancers, NSCLC [21] |
| Lapatinib | HER2 (ERBB2) Hormone receptor |
No No |
Breast neoplasms [22] |
| Letrozole | Hormone receptor | No | Breast neoplasms |
| Bevacizumab * | VEGF * | No | Colorectal neoplasms, ovarian- and breast neoplasms, NSCLC, renal cell carcinoma [23] |
| Cetuximab | BRAF EGFR KRAS |
Yes (FDA) Yes (FDA, HCSC) Yes (FDA, PMDA, HCSC) |
Head and neck neoplasms, colorectal neoplasms [24] |
| Erdafitinib | FGFR2/3 | Yes (FDA) | Urothelial carcinoma ** [25] |
FDA = Food and Drug Administration (USA), HCSC = Health Canada/Santé Canada (Canada), PMDA = Pharmaceuticals and Medical Devices Agency (Japan). * Biomarker/medicinal product not found by previous search. Plasma VEGF is not a predictive biomarker for the treatment with bevacizumab, even though it is a VEGF-targeted therapy. Bevacizumab therapy is part of the standard of care for solid tumors [26]. ** For erdafitinib, there is no marketing authorization in the EU, although it received accelerated approval for urothelial carcinoma from the US FDA in 2019 [25].