FOLFIRI is an irinotecan-based chemotherapy regimen, which is frequently used in first-line colorectal cancer treatment in Europe.
The approval from the new indication is based on data from trials, which evaluated Vectibix plus FOLFIRI in the first-line setting.
Amgen Global Development senior vice-president Elliott Levy said: "Colorectal cancer is the second most common cancer in Europe, and additional treatment options are important for patients and for physicians treating this serious disease.
"The European Commission approval of Vectibix as a first-line treatment in combination with FOLFIRI chemotherapy means physicians have another treatment option for adult patients with wild-type RAS metastatic colorectal cancer."
In the European Union (EU), Vectibix is approved to treat adults with WT RAS mCRC: in first-line in combination with FOLFOX or FOLFIRI; in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
Vectibix is also indicated as monotherapy after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.