Lilly's Cyramza in Combination with Paclitaxel Granted FDA Approval for Advanced Gastric Cancer After Prior Chemotherapy

Eli Lilly and Company has announced today that the FDA has approved Cyramza (ramucirumab) 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. Cyramza now has two FDA approvals for these patients. This announcement follows the April approval of Cyramza as a single agent — the first approval of a treatment in the US for patients in this setting.

"This FDA approval of Cyramza represents another milestone for people battling this devastating and difficult-to-treat disease," said Richard Gaynor, Senior Vice President, product development and medical affairs for Lilly Oncology. "Lilly is pleased to continue delivering on its commitment to provide new treatment options to people living with cancer and those who care for them."

Stomach cancer is the fifth most common cancer in the world and is the third-leading cause of cancer death. In the US, approximately 22,000 people will be diagnosed with stomach cancer in 2014. Cyramza (ramucirumab injection 10 mg/mL solution) 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.

This FDA approval for Cyramza is based on the Phase III Rainbow trial, which compared Cyramza plus paclitaxel to placebo plus paclitaxel. Efficacy endpoints in the trial included the major efficacy outcome measure of overall survival and the supportive efficacy outcome measures of progression-free survival and objective response rate. 

Cyramza has been granted Orphan Drug Designation by the FDA for this indication.