Aflibercept, an angiogenesis inhibitor, has been approved as a second-line treatment for metastatic colorectal cancer in combination with the FOLFIRI chemotherapy regimen, the Food and Drug Administration announced.
The indication is for patients whose tumors are resistant to, or have progressed after, an oxaliplatin-containing chemotherapy regimen, according to the FDA statement. The FOLFIRI regimen comprises folinic acid (leucovorin), 5-fluorouracil, and irinotecan.
Approval was based on the phase III VELOUR study of 1,226 patients with metastatic colorectal cancer whose disease progressed during treatment with oxaliplatin-based combination chemotherapy or whose tumor was surgically removed but recurred within 6 months after treatment with oxaliplatin-based combination chemotherapy. Patients continued treatment until cancer progression or unacceptable adverse effects.
The addition of aflibercept was associated with improvements in median overall survival and response rate and with a delay in tumor progression and growth: Overall survival reached a median of 13.5 months among those treated with aflibercept and FOLFIRI, vs. 12 months among those treated with placebo and FOLFIRI. Tumor size was reduced in 20% of those on the combination regimen and 11% of those receiving FOLFIRI plus placebo. In addition, median progression-free survival among patients given aflibercept and FOLIRI was 6.9 months, compared with 4.7 months in the placebo group.