Portrazza Approved by FDA to Treat Certain Lung Cancers
The Food and Drug Administration (FDA) has approved a new treatment option for patients suffering from advanced (metastatic) squamous non-small cell lung cancer (NSCLC).
The agency announced that it would issue an approval for Portrazza (necitumumab) to be used in combination with certain forms of chemotherapy for patients who have not previously received medication specifically for treating their advanced lung cancer. Portrazza is a monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors.
"Lung cancer tumors can be varied, so treatment options need to be tailored to the specific type of lung cancer in the patient," Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a written statement. "Today's approval provides certain patients with squamous cell lung cancer a new option that may extend survival."
The safety and efficacy of Portrazza were evaluated in a multicenter, randomized, open-label clinical study of more than 1,000 participants. 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.
Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015. The most common type of lung cancer, non-small cell lung cancer, is further divided into two main types named for the kinds of cells found in the cancer – squamous cell and non-squamous cell (which includes adenocarcinoma).