# Necitumumab

Source: https://onco.cc/drugs/necitumumab/  
OnCo record `necitumumab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: nci-list
- 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: US 2015: First-line metastatic squamous NSCLC with gemcitabine and cisplatin; EU 2016: EGFR-expressing locally advanced or metastatic squamous NSCLC with gemcitabine and cisplatin

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Necitumumab
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=necitumumab
- NCI drug page: https://www.cancer.gov/about-cancer/treatment/drugs/necitumumab
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/portrazza

## Connected records

- drugs: [Cetuximab](https://onco.cc/drugs/cetuximab/), [Gemcitabine + cisplatin](https://onco.cc/drugs/gemcitabine-cisplatin/)
- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Squamous cell carcinoma of the lung](https://onco.cc/cancers/lung-squamous-cell-carcinoma/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- companies: [Eli Lilly (incl. Loxo)](https://onco.cc/companies/eli-lilly/)
- trials: [Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)](https://onco.cc/trials/nct03944772/), [SQUIRE](https://onco.cc/trials/squire/)
- terms: [Lung cancer: the failed and stopped programmes, and why](https://onco.cc/terms/lung-failed-programmes/)

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