Table 1 Targeted agents for the treatment of metastatic NSCLC
Generic drug name | Target | Approved population | Type | EMA approved treatment regimens in NSCLC | FDA approved treatment regimens in NSCLC |
|---|---|---|---|---|---|
Afatinib | EGFR | EGFR positive NSCLC patients | Tyrosine-kinase inhibitor | Under review | Under review |
Bevacizumab | VEGF | All NSCLC patients | Recombinant humanized monoclonal antibody | In addition to platinum-based chemotherapy for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology (Aug 2007) | Non-squamous NSCLC, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced recurrent or metastatic disease (Oct 2006) |
Cetuximab | EGFR | Â | Chimeric monoclonal IgG1 antibody | None; Merck KGaA withdrew its application formally in Sep 2012 | - |
Crizotinib | ALK | ALK positive NSCLC patients | Anaplastic lymphona kinase inhibitor | Adult patients with previously treated ALK-positive NSCLC (Oct 2012) | Patients with locally advanced or metastatic NSCLC that is ALK-positive as detected by an FDA-approved test (Aug 2011) |
Erlotinib | EGRF | EGFR positive NSCLC patients | Tyrosine-kinase inhibitor | Patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen (Oct 2005) | • Treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen (Nov 2004) |
• Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy (April 2010) | |||||
• First-line treatment of metastatic NSCLC patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (May 2013) | |||||
Monotherapy for the continued treatment of patients with locally advanced or metastatic NSCLC after failure of both platinum-based and docetaxel chemotherapies who are benefiting or have benefited (May 2003). The approval was limited to cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from gefitinib treatment (Jun 2005) | |||||
Gefitinib | EGFR | EGFR positive NSCLC patients | Tyrosine-kinase inhibitor | Adult patients with locally advanced or metastatic NSCLC with activating mutations of EGFR (Jun 2009) | Â |