Eli Lilly's Stomach Cancer Drug Approved By The FDA

Eli Lilly and Co. has announced that they will be putting their stomach cancer drug, Cyramza (ramucirumab), on the market after it received federal marketing approval by the FDA this past Monday. Industry analysts believe that the company is hoping that Cyramza will be able to replace the declining sales of several company drugs that recently lost their patent protection. A vascular endothelial growth factor Receptor 2 antagonist, Cyramza works by inhibiting the growth of blood vessels that supply blood to cancer tumors, allowing them to grow. It was designed for treating patients whose cancer cannot be handled surgically, or patients with cancer that has spread to another part of the body. The drug was initially created by ImClone Systems, which Eli Lilly acquired in 2008. Eli Lilly eventually hopes to also receive FDA approval for Cyramza’s treatment of a host of other diseases, including lung, liver, and colorectal cancers.

The Cyramza label includes a Boxed Warning advising of the increased risk of severe and sometimes fatal hemorrhage events. The most common side effects included hypertension, diarrhea, and headache, and hyponatremia.

Richard Gaynor, MD and SVP of product development and medical affairs for Lilly Oncology, released a statement on the approval. “Lilly Oncology is committed to delivering innovative medicines that extend the lives of people with cancer,” said Gaynor. “Until now, there were no FDA-approved options for patients in this indication. We are pleased that the FDA has approved CYRAMZA for these patients. This is an aggressive disease that is difficult to treat, and the prognosis has typically been very poor.”

Stomach cancer usually affects aging adults, and the National Cancer Institute estimates that 22,220 Americans will be diagnosed with stomach cancer in this year alone.