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FDA Expands Labeling for Cyramza (Ramucirumab) to Include Metastatic NSCLC
The FDA has expanded the approved use of Cyramza (ramucirumab, Eli Lilly) to treat patients with metastatic non–small-cell lung cancer (NSCLC).
The National Cancer Institute estimates that 224,210 Americans will be diagnosed with NSCLC, the most common type of lung cancer, in 2014, and that 159,260 will die from the disease.
Ramucirumab works by blocking the blood supply that fuels tumor growth. The drug is intended for patients whose tumor has progressed during or after treatment with platinum-based chemotherapy. It is to be used in combination with docetaxel, another type of chemotherapy.
The new approval is the third indication that Cyramza has received in 2014. In April, the FDA approved Cyramza as a single agent to treat patients with advanced stomach cancer or gastroesophageal-junction (GEJ) adenocarcinoma. In November, the agency expanded the drug’s use in treating patients with advanced gastric or GEJ adenocarcinoma to include paclitaxel, another chemotherapy agent.
The approval of Cyramza plus docetaxel for metastatic NSCLC was based on results from a clinical study of 1,253 participants with previously treated, progressive lung cancer. The subjects were randomly assigned to receive ramucirumab plus docetaxel or placebo plus docetaxel. The treatments were administered until disease progression or intolerable adverse effects occurred. The study was designed to measure overall survival.
The results showed that half of the participants treated with ramucirumab plus docetaxel survived an average of 10.5 months from the start of treatment compared with an average of 9.1 months from the start of treatment for half of the participants who received placebo plus docetaxel.
The most common adverse effects associated with ramucirumab plus docetaxel included neutropenia, fatigue, and stomatitis. Ramucirumab can cause severe bleeding, blood clots, and hypertension, and may impair wound healing.
Source: FDA; December 12, 2014.