FDA Extends Cyramza Approval to Metastatic Non-small Cell Lung Cancer

FDA Extends Cyramza Approval to Metastatic Non-small Cell Lung Cancer

FDA approvedThe U.S. Food and Drug Administration (FDA) has expanded the use of Cyramza (ramucirumab) to include patients suffering from metastatic non-small cell lung cancer (NSCLC) — the most common type of lung cancer — which affects about 224,210 people in the United States alone and killed 159,260 in 2014, according estimations from the National Cancer Institute.

NSCLC is caused by the formation of cancer cells in the tissues of the lung. Cyramza works by blocking blood supply to the tumor in order to prevent further growth. The medication is now recommended to treat patients with tumors that have progressed during or after being treated with platinum-based chemotherapy. The FDA indicated that the drug will be used in a combined therapy with docetaxel, another type of chemotherapy.

The approval of the drug combination for the treatment of NSCLC has been granted based on the results of a clinical study conducted with 1,253 volunteers who had already been treated and still had progressive lung cancer. The participants in the random trial were given either Cyramza plus docetaxel or a placebo plus docetaxel, and observed for disease progression or development of intolerable side effects.

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The results of the study, which was designed to evaluate overall survival and the length of time each participant lived before death, revealed that half of the patients who were administered Cyramza plus docetaxel survived an average of 10.5 months from the start of treatment, while the group that was treated with placebo plus docetaxel registered an average of 9.1 months from the start of treatment.

In addition, common side effects reported by the participants treated with Cyramza and docetaxel in the clinical trial were the decrease of infection-fighting white blood cells called neutrophils (neutropenia), fatigue and inflammation of the lining of the mouth (stomatitis). Cyramza can also cause severe bleeding, blood clots, elevation in blood pressure and may impair wound healing.

The decision of the FDA to review Cyramza’s applications and include this new use was made as a result of the agency’s priority review program, which offers an expedited analysis of a medication that had previously been approved as treatment for severe diseases or conditions and is expected to improve the lives of patients and offer better results then the products currently on the market.

“Today’s approval is the third indication that Cyramza has received in 2014,” stated the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, Richard Pazdur, M.D., about Cyramza, which is marketed by the Indianapolis-based Eli Lilly and Company. “The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients.”

The drug was approved by the FDA on April 21 as a single agent indicated for patients with advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma, which is a type of cancer that develops in the area where the esophagus connects to the stomach. In addition, the FDA had already expanded Cyramza’s use on November 5 to also include patients suffering from advanced gastric or GEJ adenocarcinoma.

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