FDA Approves Second-Line Treatment for Metastatic Colorectal Cancer
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.
- Ramucirumab for Patients with AFP-High Hepatocellular Carcinoma Granted FDA Approval