FDA approves Lilly's Portrazza for advanced squamous NSCLC

The US Food and Drug Administration yesterday approved pharma major Eli Lilly’s (NYSE: LLY) Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Lilly’s shares edged up 1.3% to $84.98 in after hours trading.

“Lung cancer tumors can be varied, so treatment options need to be tailored to the specific type of lung cancer in the patient,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides certain patients with squamous cell lung cancer a new option that may extend survival.”

Portrazza is a monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors. Lung cancer is the leading cause of cancer death in the USA, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the FDA.