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FDA approves Portrazza for advanced squamous NSCLC
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The FDA today approved necitumumab in combination with two forms of chemotherapy to treat patients with previously untreated advanced squamous non–small cell lung cancer, according to a press release.
Necitumumab (Portrazza, Eli Lilly and Company) is a monoclonal antibody that blocks activity of EGFR, a protein typically found on squamous NSCLC tumors.
Richard Pazdur
“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, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Today’s approval provides certain patients with squamous cell lung cancer a new option that may extend survival.”
The FDA based its approval in part on safety and efficacy data from an open-label, randomized study of 1,093 patients who received gemcitabine (Gemzar, Eli Lilly and Company) and cisplatin with or without necitumumab.
Patients assigned necitumumab with the two forms of chemotherapy achieved a median OS of 11.5 months, whereas patients assigned only chemotherapy achieved a median OS of 9.9 months.
Necitumumab appeared to have no effect on treatment in patients with non-squamous NSCLC.
The most common adverse events associated with necitumumab included skin rash and hypomagnesemia. Necitumumab contains a box warning regarding the risk for hypomagnesemia, as well as the risks for cardiac arrest and sudden death.