FDA Approves Eli Lilly's Cyramza for Treatment of Advanced Stomach Cancer

Eli Lilly's Cyramza (ramucirumab) is now approved for treatment of advanced stomach cancer, the Food and Administration announced Monday.

Cyramza can now be used to treat people with gastroesophageal junction adenocarcinoma, which affects the region of the digestive system where the esophagus joins the stomach.

According to the National Cancer Institute, some 22,000 people will be diagnosed with stomach cancer in 2014. The overall incidence of stomach cancer in the United States has declined in the past 75 years.

"Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Cyramza is new treatment option that has demonstrated an ability to extend patients' lives and slow tumor growth."

Cyramza belongs to a class of drugs called angiogenesis inhibitors, which work by blocking the supply of blood to the tumor. The drug is for use in patients whose cancer has spread to other parts of the body.

The drug's safety and efficacy were tested on a group of 355 participants who were suffering from advanced stomach cancer. Two-thirds of the participants were kept on the test drug while the rest received placebos. The trial was designed to measure overall survival or the length of time that the patients lived, according to a news release.

Researchers found that the drug increased overall survival and even halted tumor's growth. In another clinical trial, researchers kept a group of patients on a combination of Cyramza plus paclitaxel (a cancer drug) and paclitaxel. They found that the combination was more effective in improving overall survival.

Diarrhea and high blood pressure are the common side-effects of using the drug, FDA said.

According to Mark Schoenebaum, a New York-based analyst with ISI Group, ramucirumab could generate $600 million for Eli Lilly in annual sales, Bloomberg reported. Lilly grew by 4.1 percent to close at $52.53 in New York trading.