{"entity":{"id":"necitumumab","kind":"drug","name":"Necitumumab","aka":[],"tldr":"Necitumumab (Portrazza) is an antibody added to gemcitabine and cisplatin as first treatment for squamous non-small cell lung cancer that has spread; the benefit is modest and it is little used.","summary":"Necitumumab was approved by the FDA in November 2015 in combination with gemcitabine and cisplatin for first-line metastatic squamous NSCLC, on the SQUIRE trial (1,093 patients) in which adding the antibody produced a small but statistically significant gain in overall survival, while the INSPIRE trial in non-squamous disease was stopped for lack of benefit and excess thromboembolic deaths. The EU authorised Portrazza in 2016 for EGFR-expressing squamous NSCLC. Cardiopulmonary arrest and hypomagnesaemia carry boxed warnings; rash is universal. Immunotherapy-chemotherapy combinations (KEYNOTE-407) have since made it largely obsolete, and it is listed by the NCCN only as an option in selected patients.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Necitumumab","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=necitumumab"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/necitumumab"},{"label":"EPAR","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/portrazza"}],"tags":["nci-list"],"related":["cetuximab","gemcitabine-cisplatin"],"cancers":["nsclc"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["egfr"],"drugs":[],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["nct03944772"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Portrazza","modality":"Monoclonal antibody (anti-EGFR, IgG1)","mechanism":"Fully human IgG1 that binds the EGFR ligand-binding domain, blocking ligand-induced activation and downstream MAPK and PI3K signalling.","approvals":[{"region":"US","year":2015,"indication":"First-line metastatic squamous NSCLC with gemcitabine and cisplatin"},{"region":"EU","year":2016,"indication":"EGFR-expressing locally advanced or metastatic squamous NSCLC with gemcitabine and cisplatin"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/necitumumab/","neighbours":{"drug":[{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"}],"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"lung-squamous-cell-carcinoma","kind":"cancer","name":"Squamous cell carcinoma of the lung","route":"/cancers/lung-squamous-cell-carcinoma/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}],"trial":[{"id":"nct03944772","kind":"trial","name":"Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)","route":"/trials/nct03944772/"},{"id":"squire","kind":"trial","name":"SQUIRE","route":"/trials/squire/"}],"term":[{"id":"lung-failed-programmes","kind":"term","name":"Lung cancer: the failed and stopped programmes, and why","route":"/terms/lung-failed-programmes/"}]}}