Eli Lilly: FDA Grants Fourth Approval For Cyramza

(RTTNews) - Eli Lilly and Co (LLY) on Friday said it received its fourth U.S. Food and Drug Administration approval for CYRAMZA, which is also now indicated in combination with FOLFIRI chemotherapy for the treatment of patients with metastatic colorectal cancer 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.

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 and the supportive efficacy outcome measure of progression-free survival.

The labeling for CYRAMZA contains Boxed Warnings for hemorrhage, including severe and sometimes fatal events; gastrointestinal 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.