On November 5, 2014 Eli Lilly and Company reported that the U.S. Food and Drug Administration (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 (Press release, Eli Lilly, NOV 5, 2014, View Source [SID:1234500920]). CYRAMZA now has two FDA approvals for these patients. Today’s announcement follows the April approval of CYRAMZA as a single agent – the first approval of a treatment in the U.S. 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, M.D., 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.i In the U.S., approximately 22,000 people will be diagnosed with stomach cancer in 2014.ii 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. 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. See the Important Safety Information at the end of this press release and the Prescribing Information.

CYRAMZA has been granted Orphan Drug Designation by the FDA for this indication. Orphan drug status is given in the U.S. by the FDA’s Office of Orphan Products Development (OOPD) to medicines that show promise for the treatment of rare diseases.