Portrazza, Eli Lilly’s drug to treat a the most common form of advanced lung cancer, received approval from the U.S. Food and Drug Administration Tuesday, the company said.
The treatment, which is used in combination with two other chemotherapy drugs, is the first biologic approved for front-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC accounts for about 25% to 30% of all lung cancers, according to the American Cancer Society. The metastatic form of the disease currently has few treatment options and has a five-year survival rate of less than 5%.
“This is a complex disease and there is an urgent need for effective, first-line treatments,” Richard Gaynor, senior vice president for product development and medical affairs for Lilly Oncology, said in a statement.
Eli Lilly’s Portrazza works by blocking the ligand binding site of the human epidermal growth factor receptor 1, or EGFR. In short, that means the drug blocks the signal that allows the lung cancer to grow unimpeded, preventing the formation and spread of the malignant tumors.
A randomized trial of 1,093 patients found that Portrazza, when used in conjunction with chemotherapy drugs gemcitabine and cisplatin, improved overall survival of patients battling squamous NSCLC by an average of 1.6 months compared to using only the two chemo drugs. The most common side effects included skin rash and magnesium deficiency. Cardiac arrest and sudden death occurred in 3% of patients.