FDA approves Cyramza (ramucirumab) + FOLFIRI to treat metastatic colorectal cancer- Eli Lilly

Eli Lilly and Company has received its fourth FDA approval for Cyramza (ramucirumab). Cyramza (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

The approval is based on the Phase III trial known as RAISE, which compared Cyramza plus FOLFIRI to placebo plus FOLFIRI in people with mCRC who had disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Efficacy endpoints in the trial included the major efficacy outcome measure of overall survival (OS) and the supportive efficacy outcome measure of progression-free survival (PFS). The labeling for Cyarmza contains Boxed Warnings for: hemorrhage, including severe and sometimes fatal events; gastrointestinal (GI) perforation, a potentially fatal event; and impaired wound healing.Cyramza should be permanently discontinued in patients who experience severe bleeding or a GI perforation.Cyramza should be withheld prior to surgery and discontinued if a patient develops wound healing complications.