The Food and Drug Administration (FDA) has approved Portrazza (necitumumab injection; Eli Lilly) in combination with gemcitabine and cisplatin as first-line treatment for patients with metastatic squamous non-small cell lung cancer (NSCLC) who have not previously received medications for their advanced lung cancer. This is the first biologic approved for the first-line treatment of patients with metastatic squamous NSCLC.

The approval of Portrazza was based on data from SQUIRE, a Phase 3, multi-center, randomized, open-label clinical study (n=1,093) in patients with advanced squamous NSCLC who received gemcitabine and cisplatin with or without Portrazza. Patients who took Portrazza plus gemcitabine and cisplatin survived longer on average than those who only took gemcitabine and cisplatin (11.5 months vs. 9.9 months). Portrazza is not indicated for treatment of non-squamous NSCLC. 

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Portrazza, a monoclonal antibody that antagonizes EGFR activity, is intended for intravenous use. It includes a Boxed Warning to inform healthcare providers of serious risks including cardiac arrest and sudden death, as well as hypomagnesemia. 

Portrazza will be available as a 800mg/50mL (16mg/mL) strength preservative-free solution in single-dose vials. 

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