The U.S. Food and Drug Administration announced the approval of CYRAMZA (ramucirumab) for use in combination with FOLFIRI for patients with metastatic colorectal cancer who have experienced disease progression after receiving a first line regimen containing bevacizumab, oxaliplatin, and fluoropyrimidine.

The FDA’s approval comes after the results of a randomized, double-blind, multinational clinical trial that enrolled patients with metastatic colorectal cancer who progressed while receiving or within 6 months of discontinuing bevacizumab-, oxaliplatin-, and fluoropyrimidine-based combination chemotherapy.

The trial included 1,072 patients who were assigned 1:1 to receive either FOLFIRI with placebo or FOLFIRI with CYRAMZA. Treatment was administered and repeated every 2 weeks.

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Patients in the CYRAMZA arm received 8 mg/kg intravenously, which was continued until disease progression or unacceptable toxicity.

The trial’s primary endpoint was overall survival and treatment assignment was stratified by region (North America vs. Europe vs. other regions), KRAS status (wild-type vs. mutant), and time to progression from the beginning of first-line treatment (< 6 months vs. 6 months or longer).

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Patients enrolled in the trial had a median age of 62 years and 57% were men. The patients who received FOLFIRI and CYRAMZA has a statistically significant improvement in overall survival compared to patients who received FOLFIRI and placebo (HR 0.85 [95% CI: 0.73, 0.98], P=0.023, stratified log-rank test), with median overall survival rates of 13.3 and 11.7 months, respectively.

Safety data was generally consistent with CYRAMZA’s published safety data for other indications, with the exception of hypothyroidism being reported in 2.6% of patients based on thyroid monitoring in patients with mCRC.

The recommended dose and schedule in patients receiving CYRAMZA in combination with FOLFIRI after progression on a first-line bevacizumab containing regimen is 8 mg/kg administered every 2 weeks as a 60-minute IV infusion.