Healthcare company Eli Lilly and Company (NYSE:LLY) disclosed on Tuesday that it has been given US Food and Drug Administration (FDA) approval for Portrazza (necitumumab injection for intravenous use, 800 mg/50 ml) for the first-line treatment of people with metastatic squamous non-small cell lung cancer (NSCLC).

The company said the US Food and Drug Administration (FDA) has approved Portrazza (necitumumab injection for intravenous use, 800 mg/50 mL), in combination with gemcitabine and cisplatin, as the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer (NSCLC), a difficult-to-treat form of lung cancer with few treatment options, with less than 5% for the five-year survival rate.

According to the company, Portrazza is a recombinant human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human epidermal growth factor receptor 1 (EGFR). Activation of EGFR has been correlated with malignant progression, induction of angiogenesis and inhibition of apoptosis, or cell death.

In conjunction, Portrazza has been awarded orphan drug designation by the US FDA Office of Orphan Products Development (OOPD), added the company.

This approval of Portrazza is based on the results of the company's SQUIRE, an open-label, randomized, multi-center Phase III trial that compared first-line treatment with Portrazza in combination with gemcitabine and cisplatin to treatment with gemcitabine and cisplatin alone in patients with metastatic squamous NSCLC. The main outcome measure, or primary endpoint, was overall survival, concluded the company.