The FDA has approved ramucirumab, a human VEGFR2 antagonist in combination with FOLFIRI for second-line treatment of patients with metastatic colorectal cancer.
The US Food and Drug Administration (FDA) has approved ramucirumab (Cyramza), a human VEGFR2 antagonist in combination with FOLFIRI (irinotecan, folinic acid, and 5-FU) for the second-line treatment of patients with metastatic colorectal cancer.
Ramucirumab was previously approved as a single-agent or in combination with paclitaxel for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma, and for the treatment of non–small-cell lung cancer in combination with docetaxel.
The approval was based on the results of the phase III RAISE trial presented at ESMO 2015 and published recently in Lancet Oncology.
RAISE included 1,072 patients with metastatic colorectal cancer whose disease had progressed during or within 6 months of their last dose of first-line therapy.
About 50% of patients on the trial had a KRAS mutation. Patients were randomly assigned to either 8 mg/kg ramucirumab plus FOLFIRI or placebo plus FOLFIRI every 2 weeks.
Patients assigned ramucirumab had a 1.6-month improvement in overall survival compared with FOLFIRI alone (13.3 vs 11.7 months; HR = 0.844; 95% CI, 0.73-0.976; P = .0219) and a 1.2-month improvement in progression-free survival (5.7 vs 4.5 months; HR = 0.79; 95% CI, 0.70-0.90; P < .001).
The most commonly occurring adverse events were neutropenia (38% of patients assigned ramucirumab/FOLFIRI vs 23% of patients on FOLFIRI/placebo), hypertension (11.2% vs 2.8%), and diarrhea (10.8% vs 9.7%).
“[Ramucirumab] now has approvals in advanced or metastatic forms of three of the world’s most common and deadly cancers-gastric, non–small-cell lung, and colorectal-with four FDA approvals received in just over a year," said Sue Mahony, PhD, senior vice president and president, Lilly Oncology, in a prepared statement.