FDA Approves Cyramza (Ramucirumab) for Non-Small Cell Lung Cancer

The US Food and Drug Administration (FDA) approved Cyramza (ramucirumab) to treat people with non-small cell lung cancer that has spread beyond the lungs (metastasized), and whose tumor grew during or after treatment with certain types of chemotherapy. It’s meant to be used in combination with the chemotherapy drug docetaxel.

Cyramza is a targeted therapy drug. It works by blocking the growth of new blood vessels that help tumors grow. It’s already approved to treat advanced stomach cancer and gastroesophageal junction adenocarcinoma, a type of cancer located where the stomach connects to the esophagus. Cyramza is given as an infusion into a vein.

The new approval is based on a study of 1,253 people with metastatic non-small cell lung cancer that kept growing during or after previous treatment. Results showed that participants who received Cyramza plus docetaxel survived an average 10 ½ months from the start of treatment compared to an average of about 9 months for participants who received only docetaxel.

The FDA reviewed the new use of Cyramza under its priority review program, which is designed to speed up the review process for drugs that have the potential for treating a serious disease.

The most common side effects from the Cyramza-docetaxel combination included a decrease in infection-fighting white blood cells, fatigue, and inflammation of the lining of the mouth. Cyramza can also cause severe bleeding, blood clots, elevation in blood pressure and may impair wound healing.

Cyramza is marketed by Eli Lilly.

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