FDA Approves Antibody Treatment for Lung Cancer

(National Cancer Institute)

25 November 2015. U.S. Food and Drug Administration yesterday approved necitumumab, an engineered antibody to treat squamous non-small cell lung cancer that spreads to other parts of the body. Necitumumab is marketed under the brand name Portrazza by Eli Lilly and Company.

Worldwide, lung cancer causes some 1.6 million deaths, according to World Health Organization. Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85 percent of all cases. American Cancer Society estimates more than 221,000 new cases of lung cancer will be diagnosed in the U.S. during 2015, affecting somewhat more men than women, leading to 158,000 deaths.

Squamous cell lung cancer begins in thin squamous cells in respiratory tracts. The company cites data showing squamous non-small cell lung cancer that metastasizes, or spreads to other parts of the body is difficult to treat, and metastasizing cancer has less than a 5 percent survival rate over 5 years.

Portrazza is a monoclonal antibody, a biologic drug designed to address specific disease-causing proteins, in this case the epidermal growth factor receptor or EGFR, which when mutates sends signals that encourage tumor growth in the lungs. The drug acts by blocking the ability of EGFR proteins to bind to their target sites, and thus preventing the signals that promote tumor cell proliferation.

FDA based its approval in part on results of a late-stage clinical trial with nearly 1,100 participants, where individuals having metastasizing squamous non-small cell lung cancer were given two chemotherapy drugs — gemcitabine and cisplatin — then randomly assigned to receive Portrazza or continue with chemotherapy alone. Participants receiving Portrazza plus chemotherapy survived for 11.5 months on average, compared to 9.9 months for those receiving chemotherapy alone.

The drug is approved for patients who have not received other treatments for lung cancer. In addition, the approval only covers Portrazza’s use with the same two chemotherapy drugs, gemcitabine and cisplatin, evaluated in the clinical trial.

Portrazza will be marketed with a boxed warning of treatment risks, including cardiac arrest and sudden death, as well as a magnesium deficiency that can cause muscular weakness, seizure, and potentially fatal irregular heartbeats. During the drug’s development, FDA granted Portrazza orphan drug designation for therapies designed to address rare conditions or disorders.

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