FDA Approves Eli Lilly's Cyramza For Gastric Cancer

Eli Lilly announced via press release that the Food and Drug Administration (FDA) has approved Cyramza (ramucirumab). The treatment is indicated for patients with advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy. Lilly purchased the Cyramza molecule from ImClone Systems in 2008. Lilly intends to provide the drug to patients in the next few weeks. Richard Gaynor, SVP at Lilly Oncology said, "Until now, there were no FDA-approved options for patients in this indication. This is an aggressive disease that is difficult to treat, and the prognosis has typically been very poor."

Cyramza

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist. The drug inhibits angiogenesis, the forming of new blood vessels. In normal tissues, angiogenesis is desired behavior, but in tumor cells, new blood vessels allow the cancer to grow. The drug is administered intravenously every two weeks.

The FDA reviewed clinical studies when issuing the approval, including the REGARD multicenter study. Over 300 patients in 29 countries took part in the study. Patients with gastric cancer previously treated with chemotherapy showed improvement in progression-free survival and overall survival. Compared to a placebo, Cyramza patients increased their median overall survival by 37 percent.

Gastric Cancer

Gastric cancer begins in the stomach. Cancer cells form in the stomach and develop slowly, often undetected. It may stay localized or travel to other parts of the body such as the bones, lungs, and liver. People with a family history of gastric cancer are more susceptible. A deadly disease, gastric cancer is the third leading cause of cancer deaths. In 2014, an estimated 22,000 people in the U.S. will be diagnosed with gastric cancer. The FDA, in its press release on the approval, said that while gastric cancer rates have declined over the past 40 years, patients need new therapies especially when they do not respond to other therapies.

Lilly’s PatientOne Program

Eli Lilly has developed the PatientOne program to provide support to gastric cancer patients, caregivers, and physicians. The program helps address insurance coverage and financial issues arising from taking a Lilly oncology product.