Table 3.
US FDA-Approved Drugs and Companion Diagnostics for Advanced NSCLC
| Targeted Agent | Companion Diagnostic Test |
|---|---|
| EGFR | |
| Erlotinib | Cobas® EGFR Mutation Test v2 |
| Gefitinib | Therascreen EGFR RGQ PCR Kit |
| Afatinib | Therascreen EGFR RGQ PCR Kit |
| Osimertinib | Cobas® EGFR Mutation Test v2 |
| ALK | |
| Crizotinib | Vysis ALK Break Apart FISH Probe Kit |
| Ceritinib | Ventana ALK (D5F3) CDx Assay |
| Alectinib | Ventana ALK (D5F3) CDx Assay |
| Lorlatinib | Ventana ALK (D5F3) CDx Assay |
Note: Adapted with permission from Schwartzberg L, Kim ES, Liu D, Schrag D. Precision oncology: who, how, what, when, and when not? Am Soc Clin Oncol Educ Book. 2017;37:160–16988 with data from these studies.106,193
Abbreviations: ALK, anaplastic lymphoma kinase; CDx, companion diagnostic test; EGFR, epidermal growth factor receptor; FDA, Food and Drug Administration; FISH, fluorescence in situ hybridization; NSCLC, non-small-cell lung cancer; PCR, polymerase chain reaction; RGQ, Rotor-Gene Q.