The U.S. Food and Drug Administration (FDA) has approved necitumumab (Portrazza) in combination with gemcitabine and cisplatin for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) who have not received prior therapy for advanced disease.1
“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, MD, 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.”
Necitumumab is a monoclonal antibody that inhibits epithelial growth factor receptor (EGFR) activity.
Approval was based on an open-label clinical trial that evaluated the safety and efficacy of necitumumab in combination with gemcitabine and cisplatin compared with gemcitabine plus cisplatin alone in 1093 patients with advanced squamous NSCLC. Results showed that median overall survival was 11.5 months with necitumumab vs 9.9 months without it.
The most common adverse events of necitumumab were rash and hypomagnesemia. Healthcare providers should also be aware that necitumumab carries a boxed warning alerting them of serious risks of cardiac arrest and sudden death, and hypomagnesemia in patients taking necitumumab.
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Necitumumab was not found to be effective for the treatment of patients with non-squamous NSCLC in a trial that evaluated necitumumab in combination with cisplatin and pemetrexed.
- FDA approves Portrazza to treat advanced squamous non-small cell lung cancer [news release]. Silver Spring, MD: U.S. Food and Drug Administration; November 24, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncPressA/ucm474131.htm. Accessed November 24, 2015.