New Stomach Cancer Rx Approved

Stomach cancer prescription Cyramza approved by FDA may also help gastroesophageal junction adenocarcinoma

(RxWiki News) Some stomach cancer patients who have gone through chemotherapy but still have not recovered from their condition may now have a new treatment option.

The US Food and Drug Administration (FDA) announced approval of a new medication to treat certain forms of stomach cancer.

The medication, ramucirumab, sold under the brand name Cyramza, was found to increase the lives of patients by several months in a clinical trial.

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Cyramza, manufactured by the pharmaceutical company Eli Lilly, is the first medication of its kind — a medication intended for patients with advanced cancer whose disease is continuing to progress even after receiving chemotherapy.

Those with advanced stage stomach cancer or gastroesophageal junction adenocarcinoma, a cancer that develops where the esophagus meets the stomach, may potentially benefit from this new medication.

According to the FDA, the medication works to block the blood supply to tumors in patients for whom surgical removal of the tumors is not an option or for whom the cancer has spread after chemotherapy.

A trial involving 355 such patients led by Charles Fuchs, MD, MPH, of the Dana-Farber Cancer Institute, was conducted to test the safety and effectiveness of Cyramza.

Patients were divided into two groups — one group received Cyramza, and one group received a placebo (an inactive medication replacement). The researchers then measured how long the patients lived ("survival time").

Dr. Fuchs and team found that compared to the placebo, Cyramza increased the average survival time of patients by 37 percent. Those who received Cyramza survived an average of 5.2 months, while those who received a placebo survived an average of 3.8 months.

"Additionally, participants who took Cyramza experienced a delay in tumor growth (progression-free survival) compared to participants who were given placebo," explained the FDA.

According to Eli Lilly, the most commonly reported reactions to the medication included high blood pressure, which occurred in 16 percent of Cyramza patients and 8 percent of placebo patients; diarrhea, which occurred in 14 percent of Cyramza patients and 9 percent of placebo patients; and headache, which occurred in 9 percent of Cyramza patients and 3 percent of placebo patients.

In an FDA press release, Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, explained the importance of the development of new medications for these conditions.

“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 Dr. Pazdur. "Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”

Cancer patients should discuss treatment options with their physicians.

For more information, please visit The Dana-Farber Cancer Institute.

Review Date: 
April 22, 2014