Eli Lilly and Company has announced that ramucirumab (Cyramza) plus leucovorin, fluorouracil (5-FU), and irinotecan (FOLFIRI), compared with placebo, improved overall survival in patients with metastatic colorectal cancer (mCRC) whose disease progressed after bevacizumab, oxaliplatin, and a fluoropyrimidine.
In addition, the global, randomized, double-blind, phase 3 study demonstrated a statistically significant improvement in progression-free survival (PFS) in patients that took ramucirumab in combination with FOLFIRI compared to those that took placebo plus FOLFIRI. The most common adverse effects in patients taking the ramucirumab combination were diarrhea, fatigue, hypertension, and neutropenia.
The U.S. Food and Drug Administration (FDA) initially approved ramucirumab for intravenous infusion in 2014 for the treatment of patients with advanced gastric cancer or gastro-esophageal junction adenocarcinoma whose disease progressed after fluoropyrimidine- or platinum-containing chemotherapy. The most common adverse effects associated with ramucirumab are hypertension and diarrhea. Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist. Patients receiving ramucirumab should be premedicated with an intravenous histamine antagonist like diphenhydramine hydrochloride.
Eli Lilly and Company plans to submit ramucirumab to the U.S. FDA for the treatment of patients with mCRC whose disease has progressed after bevacizumab, oxaliplatin, and a fluoropyrimidine.
Eli Lilly and Company today announced that the RAISE trial, a Phase III study of ramucirumab (CYRAMZA™) in combination with chemotherapy in patients with metastatic colorectal cancer (mCRC), met its primary endpoint of overall survival.
The global, randomized, double-blind study compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI as a second-line treatment in patients with mCRC after treatment with bevacizumab, oxaliplatin and a fluoropyrimidine in the first-line setting. RAISE showed a statistically significant improvement in overall survival in patients treated with ramucirumab plus FOLFIRI compared to placebo plus FOLFIRI.