FDA approves Portrazza (necitumumab) to treat metastatic squamous NSCLC- Eli Lilly

Eli Lilly and Company announced that the 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). 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.The five-year survival rate for patients with metastatic disease is less than five percent. Portrazza has been granted Orphan Drug Designation by the FDA.

The safety and efficacy of Portrazza were evaluated in a multicenter, randomized, open-label clinical SQUIRE study of 1,093 participants with advanced squamous NSCLC who received the chemotherapies gemcitabine and cisplatin with or without Portrazza. Those taking Portrazza plus gemcitabine and cisplatin lived longer on average (11.5 months) compared to those only taking gemcitabine and cisplatin (9.9 months).Portrazza was not found to be an effective treatment in patients with non-squamous NSCLC.The labeling for Portrazza contains Boxed Warnings regarding cardiopulmonary arrest and hypomagnesemia.

Comment: Metastatic squamous NSCLC is extremely difficult to treat with few treatment options and patients with metastatic disease have a five-year survival rate of less than five percent.