FDA Approves Second-Line Treatment for Metastatic Colorectal Cancer

April 24, 2015
Meghan Ross, Associate Editor

The FDA today approved a second-line treatment for metastatic colorectal cancer.

The FDA today approved a second-line treatment for metastatic colorectal cancer (mCRC).

Manufacturer Eli Lilly and Company announced that ramucirumab (Cyramza) is now approved to be used with irinotecan, folinic acid, and 5-fluorouracil (Folfiri) for the treatment of mCRC with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

A trial comparing Cyramza and Folfiri with placebo and Folfiri among patients with mCRC who had disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine, found that the combined intervention was effective in overall survival and progression-free survival (PFS). The trial found that Cyramza and Folfiri treatment reduced the risk of patient death by 15%. In addition, the intervention group reached PFS at an average of 5.7 months as opposed to the control group’s 4.5-month average.

"Cyramza now has approvals in advanced or metastatic forms of 3 of the world's most common and deadly cancers (gastric, non-small cell lung, and colorectal) with 4 FDA approvals received in just over a year," Sue Mahony, PhD, senior vice president and president, Lilly Oncology, said in a press release. "This progress is encouraging and supports our ongoing development program for Cyramza.

Boxed warnings for Cyramza include hemorrhage, gastrointestinal perforation, and impaired wound healing.

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