FDA approves Cyramza in combination with paclitaxel for advanced gastric cancer after prior chemotherapy

FDA has approved ramucirumab (Cyramza, Eli Lilly) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

FDA drug approvals-November 2014

Cyramza now has 2 FDA approvals for these patients. In April, the drug as a single agent was the first approval of a treatment in the United States for patients in this setting. Cyrazma is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) receptor 2 antagonist that specifically binds and blocks activation of VEGF receptor 2, by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Cyrazma inhibited angiogenesis (the process of making new blood vessels) in an in vivo animal model.

"Any time we can add to the tools for combatting cancer is very important,” FormularyWatch advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City. “The fact that the drug can be used by itself to treat certain malignancies is impressive and now that it is FDA approved, researchers will be able to assess the drug’s use when combined with other types of therapy.”

Cyramza is the only FDA-approved second-line treatment option for patients with advanced or metastatic gastric or GEJ adenocarcinoma whose disease has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

“Cyramza, approved earlier this year for stomach cancer, is a key product in Lilly’s oncology portfolio,” said John Santilli, of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries. “With the colorectal cancer market becoming increasingly crowded, Lilly will need to review the pricing strategy for Cyramza to make sure the drug remains competitive in this market.” 

Stomach cancer is the fifth most common cancer in the world and is the third-leading cause of cancer death. In the United States approximately 22,000 people will be diagnosed with stomach cancer in 2014.

FDA approved Cyramza based on the phase 3 RAINBOW trial, which compared Cyramza plus paclitaxel to placebo plus paclitaxel. Efficacy end points included the major efficacy outcome measure of overall survival and the supportive efficacy outcome measures of progression-free survival and objective response rate. The labeling for Cyramza contains a boxed warning regarding increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. Cyramza should be permanently discontinued in patients who experience severe bleeding.

Cyramza has been granted orphan drug designation by FDA for this indication.