Portazza for lung cancer – pro
Necitumumab (Portrazza), a recombinant human IgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR), was approved by the U.S. Food and Drug Administration (FDA) in November 2015 treatment of patients with ALK-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. The efficacy and safety of necitumumab at the recommended dose were demonstrated in an open-label, global, multi-center, 2-arm, randomized trial in 1093 patients with squamous NSCLC (Trial JFCC [SQUIRE]). A 1.6-month improvement in median overall survival (OS) among patients in the gemcitabine/ cisplatin + necitumumab arm compared with those in the gemcitabine/cisplatin arm (HR = 0.842 [0.736, 0.962]; p=0.012) was demonstrated. Necitumumab was associated with a higher rate adverse events that were grade 3 or higher (72% vs 62%) and serious adverse events (48% versus 38%). Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with necitumumab.
National Comprehensive Cancer Network (NCCN) Guidelines for Non-Small Cell Lung Cancer (Version 4.2016) recommend (category 3) necitumumab for use in combination with cisplatin and gemcitabine for patients with a performance status of 0-2 as first line therapy, subsequent therapy in EGFR-positive tumors after failure of erlotinib, afatinib, or gefitinib, and subsequent therapy for ALK-positive tumors subsequent therapy after crizotinib for ALK-positive recurrent or metastatic disease.
DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016-01-27]. Available from: http://www.thomsonhc.com/.
Necitumumab (Portrazza, Prescribing Information, 2016
National Comprehensive Cancer Network®. NCCN, Lung Cancer 2016