FDA approves extension for Cyramza in Gastric Cancer - Eli Lilly

The FDA has approved Cyramza (ramucirumab), from 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) Cancer whose disease has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Cyramza now has two FDA approvals for these patients. The 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 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.