Table 2.
Recent U.S. Food and Drug Administration Approvals of Nonchemotherapy Drugs for the Treatment of Lung Cancer
| Class | Drug | Year Approved | Biomarker | Indication |
|
|---|---|---|---|---|---|
| Tumor | Sequence | ||||
| Antiangiogenic agents | Avastin (bevacizumab) | 2006 | None | Advanced nonsquamous NSCLC | First line, in combination with carboplatin/paclitaxel chemotherapy |
| Cyramza (ramucirumab) | 2014 | None | Advanced NSCLC | After failure of platinum-based chemotherapy, in combination with docetaxel | |
| Targeted drugs: EGFR | Tarceva (erlotinib) | 2013 | Cobas EGFR mutation test | EGFR exon 19 deletion or L858R mutation–positive advanced NSCLC | First-line treatment |
| Gilotrif (afatinib) | 2013 | Therascreen EGFR RGQ PCR kit | EGFR exon 19 deletion or L858R mutant advanced NSCLC | First-line treatment | |
| Gilotrif (afatinib) | 2016 | None | Advanced squamous cell lung cancer | After failure of platinum-based chemotherapy | |
| Iressa (gefitinib) | 2015 | Therascreen EGFR RGQ PCR kit | EGFR exon 19 deletion or L858R mutant advanced NSCLC | First-line treatment | |
| Tagrisso (osimertinib) | 2015 | Cobas EGFR mutation test v2 | EGFR T790M–positive advanced NSCLC | ||
| Portrazza (necitumumab) | 2015 | None | Metastatic squamous cell lung cancer | First line, in combination with cisplatin/gemcitabine chemotherapy | |
| Targeted drugs: ALK | Xalkori (crizotinib) | 2011 | ALK FISH positive (Vysis ALK FISH) | ALK-positive locally advanced or advanced NSCLC | |
| Zykadia (ceritinib) | 2014 | ALK positive | Advanced ALK-positive NSCLC | Crizotinib-refractory or intolerant | |
| Alecensa (alectinib) | 2015 | ALK positive | Advanced ALK-positive NSCLC | Crizotinib-refractory or intolerant | |
| Targeted drugs: ROS-1 | Xalkori (crizotinib) | 2016 | ROS-1 positive | Advanced ROS-1 gene alteration–positive NSCLC | |
| Immunotherapeutic agents | Keytruda (pembrolizumab) | 2015 | PD-L1 IHC 22C3 pharmDx | Metastatic NSCLC | After failure of platinum-based chemotherapy |
| Opdivo (nivolumab) | 2015 | None mandated (PD-L1 IHC 28-8 pharmDx coapproved) | Metastatic NSCLC | After failure of platinum-based chemotherapy | |
Definition of abbreviations: ALK = anaplastic lymphoma kinase; EGFR = epidermal growth factor receptor; FISH = fluorescent in situ hybridization; IHC = immunohistochemistry; NSCLC = non–small cell lung cancer; PCR = polymerase chain reaction; PD-L1 = programmed death-ligand 1; RGQ = rotor-gene Q; ROS-1 = ROS proto-oncogene-1.