On December 12, 2014, the FDA approved a new use for Cyramza® (ramucirumab), a cancer drug made by Eli Lilly Co. specifically for the treatment of metastatic nonsmall cell lung cancer (NSCLC). NSCLC is the most common form of lung cancer, occurring when cancer cells develop in lung tissue. Lung cancer is expected to kill about 159,000 people in the United States in 2014.
How it Works
Cyramza works by stopping blood flow to the tumor. It is intended to be used in conjunction with another drug, docetaxel, to treat patients whose tumors have continued to grow during or after treatment with a platinum-based chemotherapy.
Cyramza was approved under the FDA’s priority review program based on a study of about 1,300 patients. Half the patients received docetaxel plus a placebo, while the other half received docetaxel plus Cyramza. The treatment continued until “disease progression” or the development of intolerable side effects. The study measured the length of time the patients survived after beginning treatment. The patients who received Cyramza lived an average of 10.5 weeks, while those who received the placebo survived an average of 9.1 weeks.
The FDA first approved Cyramza on April 21, 2014, as a single line treatment for advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma, which occurs in the region where the esophagus joins the stomach. On November 5, 2014, the FDA approved Cyramza for use with paclitaxel to treat advanced gastric cancer or GEJ adenocarcinoma.