The Food and Drug Administration has approved Portrazza (necitumumab) for use in combination with two forms of chemotherapy for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.
Portrazza, marketed by Eli Lilly and Company, is a monoclonal antibody that blocks activity of the protein EGFR, which is 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, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news release. "This approval provides certain patients with squamous cell lung cancer a new option that may extend survival."
The drug's safety and efficacy were evaluated in a multicenter, randomized, open-label clinical study of 1,093 patients with advanced squamous NSCLC who received gemcitabine and cisplatin with or without Portrazza. Those receiving Portrazza lived 11.5 months on average compared with those receiving only the two chemotherapies, who lived 9.9 months on average. Portrazza was not found to be an effective treatment for patients with non-squamous NSCLC, according to a news release from the FDA.
The most common side effects of Portrazza are skin rash and hypomagnesemia, which can cause muscular weakness, seizure, and irregular heartbeats, and can also be fatal. Portrazza includes a boxed warning to alert health care providers of serious risks of treatment, including cardiac arrest and sudden death, as well as hypomagnesemia.
Clinical Quick Facts: Portrazza
Drug: Portrazza (necitumumab)
Approved Indication: Use in combination with two forms of chemotherapy for the treatment of patients with metastatic squamous non-small cell lung cancer who have not previously received medication specifically for treating their advanced lung cancer
Serious Side Effects: Hypomagnesemia, which can cause muscular weakness, seizure, and irregular heartbeats, and can also be fatal
Common Side Effects: Skin rash and hypomagnesemia