Necitumumab (Eli Lilly’s Portrazza) has been approved by the US drugs safety watchdog for patients with advanced squamous non-small cell lung cancer (NSCLC) who have not received other treatment for their advanced disease. It is approved for use in combination with gemcitabine and cisplatin.
The decision by the US Food and Drug Administration (FDA) follows the results of a multi-centre randomised clinical trial involving 1,093 patients with the disease.
The patients were given gemcitabine and cisplatin with or without necitumumab. Those taking necitumumab plus gemcitabine and cisplatin lived longer on average than those who only took gemcitabine and cisplatin (11.5 months versus 9.9 months, respectively). Necitumumab, a monoclonal antibody that blocks the activity of EGFR, was not an effective treatment in patients with non-squamous NSCLC.
“Lung cancer tumours can be varied, so treatment options need to be tailored to the specific type of lung cancer in the patient,” says Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The approval provides certain patients with squamous cell lung cancer a new option that may extend survival.”
The FDA has, however, given the product a black box warning because of its serious side effects, including cardiac arrest and magnesium deficiency, which can cause muscle weakness, seizure, irregular heartbeats and which can be fatal.
The product is not currently marketed in the European Union, according to the database of the European Medicines Agency.