CHMP recommends Cyramza + paclitaxel for advanced Gastric (stomach) or Gastroesophageal Junction (GEJ) Adenocarcinoma - Eli Lilly
Eli Lilly and Company announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Cyramza (ramucirumab), in adults, in combination with paclitaxel, for the treatment of advanced Gastric (stomach) or Gastroesophageal Junction (GEJ) Adenocarcinoma following prior chemotherapy and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate.
This CHMP opinion is based on results from two global, randomized, double-blind and placebo-controlled Phase III studies: RAINBOW and REGARD. RAINBOW evaluated ramucirumab in combination with paclitaxel for advanced Gastric or GEJ Adenocarcinoma after prior chemotherapy while REGARD evaluated ramucirumab as a single agent in the same setting.