FDA Approves Necitumumab to Treat Advanced Squamous NSCLC

Necitumumab is a monoclonal antibody that blocks activity of EGFR

On 24 November, 2015 the US Food and Drug Administration (FDA) approved necitumumab (Portrazza) in combination with 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.

Portrazza is a monoclonal antibody that blocks activity of EGFR.

The safety and efficacy of Portrazza were evaluated in a multicenter, randomised, open-label clinical study of 1,093 participants with advanced squamous NSCLC who received the chemotherapies gemcitabine and cisplatin with or without Portrazza.

Patients who received Portrazza plus gemcitabine and cisplatin had a median overall survival of 11.5 months compared to those only receiving gemcitabine and cisplatin (9.9 months).

Median progression-free survival was 5.7 months for patients assigned to necitumumab plus gemcitabine/cisplatin and 5.5 months for those assigned to gemcitabine/cisplatin alone.

No difference in overall response rate between arms was observed, with an overall response rate of 31% for necitumumab plus gemcitabine/cisplatin and 29% for gemcitabine/cisplatin alone.

Portrazza was not found to be an effective treatment in patients with non-squamous NSCLC.

The most common side effects of Portrazza are skin rash and hypomagnesemia, which can cause muscular weakness, seizure, irregular heartbeats and can be fatal. Portrazza includes a boxed warning to alert health care providers of serious risks of treatment with Portrazza, including cardiac arrest and sudden death, as well as hypomagnesemia. Necitumumab should be withheld for grade 3 or 4 electrolyte abnormalities. 

Portrazza is marketed by Eli Lilly and Company, based in Indianapolis, Indiana.