The US Food and Drug Administration has approved Eli Lilly and Company’s 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). Portrazza is not indicated for treatment of nonsquamous NSCLC. Metastatic squamous NSCLC is a difficult-to-treat form of lung cancer with few treatment options.

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. As demonstrated in preclinical studies, EGFR plays a role in the formation (tumorigenesis) and spread (metastasis) of tumors.

Portrazza was granted orphan drug designation by the FDA. Orphan drug status is given in the US by the FDA’s Office of Orphan Products Development (OOPD) to medicines that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

Source: Eli Lilly and Company