FDA approves Cyramza for use with FOLFIRI in second-line treatment of metastatic colorectal cancer
Posted: 27 April 2015 |
The FDA has approved Cyramza in combination with FOLFIRI chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC)…
Eli Lilly and Company has received its fourth U.S. Food and Drug Administration (FDA) approval for Cyramza (ramucirumab).
Cyramza is now also indicated in combination with FOLFIRI 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 gastric, non-small cell lung and colorectal cancers
“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, Ph.D., 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.”
FDA reviewed and approved application for Cyramza in mCRC in nine weeks
While granted a standard review, this application for Cyramza in mCRC was reviewed and approved in approximately nine weeks following its submission to the FDA. All three supplemental applications for Cyramza received FDA approval within six months from the time of submission.
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 labelling for Cyramza contains Boxed Warnings for: haemorrhage, including severe and sometimes fatal events; gastrointestinal (GI) perforation, a potentially fatal event; and impaired wound healing.
