Treatment for non-small cell lung cancer gets FDA approval

24 Nov 2015

Heeding majority advice from an advisory committee, the FDA has approved the monoclonal antibody necitumumab (Portrazza) as a first-line option for patients with advanced squamous non-small cell lung cancer (NSCLC).

Necitumumab targets the epidermal growth factor receptor. The pivotal trial of the drug involved 1,093 patients with previously untreated advanced squamous-cell non-small cell lung cancer. Patients were randomized to cisplatin-gemcitabine (Gemzar) chemotherapy with or without necitumumab.

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A “small baby step” towards new treatment options

The primary analysis showed a median overall survival of 11.5 months with the monoclonal antibody versus 9.9 months with chemotherapy alone. The 6-week improvement in overall survival was considered to be modest by some members of an FDA Oncologic Drugs Advisory Committee in the context of known and unknown risks.

The FDA ultimately sided with the committee majority and the view that approval constituted a necessary "small baby step" for a disease that has few treatment options.

The most common side effects of treatment with necitumumab are skin rash and hypomagnesemia, the latter of which can lead to muscle weakness, seizures, and cardiac arrhythmias. Labeling for drug will included a boxed warning about serious and potentially fatal side effects.

Source: MedPage Today
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