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FDA Approves Necitumumab to Treat Advanced Squamous NSCLC

Necitumumab is a monoclonal antibody that blocks activity of EGFR
27 Nov 2015
Lung and other thoracic tumours;  Anticancer agents & Biologic therapy

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.

Last update: 27 Nov 2015

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