Table 3. Main genome-guided therapies employed with ADC and their main indications.
| Drug | Approved | FDA indication | EMA indication |
|---|---|---|---|
| Erlotinib (Tarceva©) | FDA: November 2004; EMA: September 2005 | First-line in metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations | Treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen or switch maintenance treatment in stable disease |
| Gefitinib (Iressa©) | FDA: July 2015; EMA: June 2009 |
First-line in metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations | Treatment of locally advanced or metastatic NSCLC with activating EGFR mutations |
| Crizotinib (Xalkori©) | FDA: August 2011; EMA: October 2012 |
Treatment of locally advanced or metastatic ALK positive NSCLC detected by a FDA-approved test | First-line and therapy of previously treated advanced ALK positive NSCLC |
| Afatinib (Giotrif©) | FDA: July 2013; EMA: September 2013 |
First-line in metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations detected by a FDA-approved test; second-line in advanced SqCC with disease progression after treatment with platinum-based chemotherapy | Treatment of locally advanced or metastatic NSCLC with activating EGFR mutations; treatment of locally advanced or metastatic NSCLC of squamous cancer progressing on or after platinum-based chemotherapy |
| Ceritinib (Zykadia©) | FDA: April 2014 EMA: May 2015 |
Treatment of metastatic ALK positive NSCLC with disease progression on or that are intolerant to crizotinib | Treatment of locally advanced or metastatic ALK positive NSCLC |
| Osimertinib (Tagrisso©) | FDA: November 2015; EMA: February 2016 |
Treatment of locally advanced or metastatic NSCLC with EGFR T790M mutations as detected by an FDA-approved test, that has progressed on or after EGFR tyrosine kinase inhibitor therapy | Treatment of locally advanced or metastatic NSCLC with EGFR T790M mutations |
| Alectinib (Alecensa©) | FDA: December 2015 | Treatment of ALK-positive metastatic NSCLC who has progressed on or is intolerant to crizotinib | – |
| Crizotinib (Xalkori©) | FDA: March 2016 EMA: July 2016 |
Treatment of metastatic ROS1-positive NSCLC | Treatment of advanced ROS1-positive NSCLC |
| Olmutinib (Olita©) | FDA: Granted breakthrough therapy designation Approved in South Korea |
Treatment of locally advanced or metastatic EGFR T790M mutation in NSCLC | – |
| Dabrafenib (Mekinist®) + Trametinib (Tafinlar®) | FDA: granted breakthrough therapy designation | Treatment of metastatic BRAF V600E-positive and previously treated NSCLC | – |
| Osimertinib | FDA: granted breakthrough therapy designation | Treatment of metastatic NSCLC with EGFR T790M mutations and TKI resistant disease | – |
FDA, U.S. Food and Drug Administration; EMA, European Medicines Agency. Data obtained from the web pages of FDA (www.fda.org) and EMA (www.ema.europa.eu/ema/)