Cyramza Gains Extended Approval for Treatment of Non-Small Cell Lung Cancer

New Drugs , News / October 4, 2016

The FDA expanded the use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC). NSCLC is considered the most common type of lung cancer and occurs when cancer cells form in the tissues of the lung.

Cyramza works by blocking the blood supply that fuels tumor growth. The drug is intended for patients whose tumor has progressed during or following treatment with platinum-based chemotherapy, and is to be used in combination with docetaxel.

On April, the FDA approved Cyramza as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. On November, the FDA expanded Cyramza’s use to treat patients with advanced gastric or GEJ adenocarcinoma to include paclitaxel, another chemotherapy drug.

The approval of Cyramza alongside docetaxel for metastatic NSCLC is based on a clinical study of 1,253 participants with previously treated and progressive lung cancer. Study participants were randomly assigned to receive Cyramza plus docetaxel or a placebo plus docetaxel. Treatment was given until disease progression or development of intolerable side effects. The trial was designed to measure overall survival, the length of time a participant lived before death. Results showed that half of the participants treated with Cyramza plus docetaxel survived an average of 10.5 months from the start of treatment, compared to an average of 9.1 months from the start of treatment for half of the participants who received placebo plus docetaxel.

The most common side effects associated with Cyramza plus docetaxel observed in the clinical study included a decrease in infection-fighting white blood cells called neutrophils (neutropenia) fatigue and inflammation of the lining of the mouth (stomatitis). Cyramza can cause severe bleeding, blood clots, elevation in blood pressure and may impair wound healing.

The FDA reviewed Cyramza’s application for this new use under the agency’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.

Cyramza is marketed by Indianapolis-based Eli Lilly.

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