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First targeted drug for stomach cancer approved by FDA
A new drug targeting angiogenesis- new blood vessel growth- of tumours has just received approval from the U.S. Food and Drug Administration (FDA) as a second line treatment for stomach cancer after initial chemotherapy has been unsuccessful. The generic name for the drug is ramucirumab. It is a monoclonal antibody directed against the vascular endothelial growth factor (VEGF) receptor-2 on blood vessel cells. It has been approved based on the results of a clinical trial carried out by scientists in Dana-Farber Cancer Institute and the approval was announced by the manufacturers, Lilly Oncology, of Indianapolis. It will be sold under the name Cyramza.

Advanced stomach cancer is notoriously difficult to treat effectively. In 2014 an estimated 22,290 people will be diagnosed with stomach cancer in 2014; 10,990 of them will die of the disease. This is the first FDA-approved treatment for this form of cancer.

The clinical trial on which the approval was based was called REGARD and was led by Dr Charles Fuchs, director of the Gastrointestinal Cancer Center at Dana-Farber. The patients enrolled in the study had advanced or metastatic gastric cancer – cancer of the stomach – or cancer at the junction of the oesophagus with the upper part of the stomach. Their cancer had progressed in spite of initial chemotherapy treatment.

The results of the trial showed that use of ramucirumab induced improvement in survival and a reduced rate of cancer progression compared to placebo. The median overall survival of patients with advanced stomach was increased modestly by 37%, to 5.2 months compared to 3.8 months for patients on placebo. They also had a 62% increase in survival time before the cancer progressed, at 2.1 months compared to 1.3 months for placebo. The modest nature of the improvements has led some commentators to question whether ramucirumab effects are really meaningful or just marginal. Dr Fuchs explains: "The benefit is modest, but it's clearly better than what we were previously doing…. when you chip away and develop drugs in sequence, ultimately you do have meaningful clinical improvements."

Another randomised clinical trial on ramucirumab, called the RAINBOW trial, examined use of ramucirumab in combination with paclitaxel in patients with advanced stomach or gastroesophageal junction cancer. The combination prolonged overall survival from a median of 7.36 months to 9.63 months. The current FDA approval of ramucirumab does not extend to combination therapy, but Lilly Oncology plans to submit the RAINBOW data in order to seek expanded approval. These results have increased confidence that the effects of ramucirumab may be more than marginal.

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


Press release: Dana-Farber Cancer Institute; available from

Wadhwa, R., Elimova, E., Shiozaki, H., Sudo, K., Blum, M.A., Estrella, J.S., Chen, Q., Song, S. & Ajani, J.A. 2014, "Anti-angiogenic agent ramucirumab: meaningful or marginal?", Expert Review of Anticancer Therapy, vol. 14, no. 4, pp. 367-379.

Shah, M.A. 2014, "Gastrointestinal cancer: targeted therapies in gastric cancer-the dawn of a new era", Nature Reviews.Clinical oncology, vol. 11, no. 1, pp. 10-11.
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