Lilly's Cyramza (Ramucirumab) Receives Fourth FDA Approval

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.

"Cyramza now has approvals in advanced or metastatic forms of three of the world's most common and deadly cancers — gastric, non-small cell lung and colorectal — with four FDA approvals received in just over a year," said Sue Mahony, senior vice president and president, Lilly Oncology. "This progress is encouraging and supports our ongoing development program for CYRAMZA. Achieving today's milestone is another example of Lilly's commitment to people living with gastrointestinal cancers."

Dr Mahony added: "We are also pleased with the efficient and collaborative reviews we had with the FDA on these submissions." While granted a standard review, this application for Cyramza in mCRC was reviewed and approved in approximately 9 weeks following its submission to the FDA. All three supplemental applications for Cyramza received FDA approval within 6 months from the time of submission.