The Food and Drug Administration (FDA) has expanded the indication of Cyramza (ramucirumab; Eli Lilly) for use in combination with irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen.
The approval is based on results from a randomized, double-blind, multinational trial of 1,072 patients with mCRC that progressed during or within six months of discontinuation of bevacizumab-, oxaliplatin- and fluoropyrimidine-based combination chemotherapy. Patients were randomly assigned to receive FOLFIRI plus placebo or FOLFIRI plus ramucirumab; treatment cycles for both arms were repeated every two weeks with ramucirumab administration at a dose of 8mg/kg by intravenous infusion. A statistically significant overall survival (OS) improvement was observed in the FOLFIRI plus ramucirumab vs. FOLFIRI plus placebo. Median OS was 13.3 and 11.7 months for patients on the FOLFIRI plus ramucirumab and FOLFIRI plus placebo arms, respectively. Progression-free survival (PFS) was also significantly improved in the ramucirumab plus FOLFIRI arm.
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Cyramza, a human IgG1 monoclonal antibody, is already indicated for treatment of advanced or metastatic, gastric, or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy and in combination with docetaxel for treatment of metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy.
For more information call (888) 463-6332 or visit FDA.gov.