Ramucirumab (Cyramza) Receives FDA OK for Stomach Cancer

Disclosures

April 21, 2014

The US Food and Drug Administration (FDA) today approved a recombinant human monoclonal antibody for stomach cancer after it extended overall median survival of cancer patients by 1.4 months in a recent clinical trial.

The new drug, ramucirumab (Cyramza, Eli Lilly), is indicated for both advanced stomach cancer and malignancies located at the junction of the stomach and esophagus. For either type of cancer, ramucirumab is limited to patients whose cancer cannot be surgically removed or has metastasized after chemotherapy using fluoropyrimidine or platinum.

Ramucirumab works by blocking the growth of new blood vessels that nourish tumors.

The National Cancer Institute estimates that some 22,000 Americans will be diagnosed with some form of stomach cancer this year, and almost 11,000 will die from it.

In an international clinical trial dubbed REGARD and described in an article in the Lancet earlier this year, 238 patients with unresectable or metastatic stomach or gastroesophageal cancer received ramucirumab while 117 other patients received a placebo. Median overall survival for the patients treated with ramucirumab was 5.2 months compared with 3.8 months for patients taking the placebo. In addition, ramucirumab delayed tumor growth by 2.1 months versus 1.3 months with the placebo.

"The benefit is modest, but it's clearly better than what we were previously doing," said Charles Fuchs, MD, MPH, who led the REGARD clinical trial, in a press release issued by the Dana-Farber Cancer Institute in Boston, Massachusetts. Dr. Fuchs directs the Gastrointestinal Cancer Center at Dana-Farber.

"For years we have looked for new and really effective drugs for stomach cancer," said Dr. Fuchs. "We have relied on standard chemotherapies for a long time, and we've needed targeted agents based on the fundamental biology of stomach cancer."

Another clinical trial demonstrated that the combination of ramucirumab and the chemotherapy drug paclitaxel lengthened overall survival compared with paclitaxel alone.

Diarrhea and high blood pressure were common adverse events experienced by patients in the clinical testing of ramucirumab.

The FDA said today that it evaluated ramucirumab under a priority review program for drugs with the potential to be a "significant improvement in safety or effectiveness in the treatment of a serious condition." The FDA also designated ramucirumab as an "orphan product" because it treats a rare disease. The designation confers economic benefits on manufacturers so as to make commercializing a drug for a small number of patients more feasible.

More information on the FDA's approval of ramucirumab is available at the agency's Web site.

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