This article is more than 5 years old. Information may no longer be current.
FDA approves Cyramza for mCRC
Click Here to Manage Email Alerts
The FDA today announced the approval of ramucirumab for use in combination with FOLFIRI chemotherapy for the treatment of certain patients with metastatic colorectal cancer.
The current approval of ramucirumab (Cyramza, Eli Lilly) is intended for patients with metastatic colorectal cancer (mCRC) who experienced disease progression after first-line treatment with a regimen containing bevacizumab (Avastin, Genentech), oxaliplatin and fluoropyrimidine.
The FDA based its decision on results of a randomized, double-blind, multinational trial composed of 1,072 patients (median age, 62 years; 57% men) with mCRC who experienced disease progression during treatment with or within 6 months of discontinuation of bevacizumab-, oxaliplatin- and fluoropyrimidine-based combination chemotherapy.
Researchers randomly assigned patients 1:1 to receive FOLFIRI plus placebo or ramucirumab. Treatment assignment was stratified by patients’ geographic region, KRAS status and time to progression from the beginning of first-line treatment (less than 6 months vs. 6 months or longer).
Both arms began a new treatment cycle every 2 weeks. Patients in the experimental arm received 8 mg/kg ramucirumab intravenously every 2 weeks until disease progression or unacceptable toxicity.
The study’s primary endpoint was OS.
Patients who received FOLFIRI plus ramucirumab demonstrated a statistically significant improvement in OS compared with patients who received FOLFIRI plus placebo (HR = 0.85; 95% CI, 0.73-0.98). Median OS was 13.3 months in the ramucirumab arm vs. 11.7 months in the placebo arm.
The addition of ramucirumab to FOLFIRI also conferred a significant improvement in PFS (HR = 0.79; 95% CI, 0.7-0.9). Median PFS was 5.7 months in the ramucirumab arm vs. 4.5 months in the placebo arm.
The safety data were in line with the safety profile observed in previously approved indications, although thyroid monitoring confirmed that 2.6% of patients experienced hypothyroidism.