FDA Oks Cyramza Combined With Paclitaxel For Gastric Cancer Prior Chemotherapy

(RTTNews) - Eli Lilly and Co (LLY) said Wednesday the U.S. Food and Drug Administration 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. 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.

Stomach cancer is the fifth most common cancer in the world and is the third-leading cause of cancer death. In the U.S., 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.

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 the FDA for this indication.