Amgen has submitted Supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) for first- and second-line use of Vectibix in combination with chemotherapy in patients with wild-type KRAS metastatic colorectal cancer (mCRC). The sBLA submissions are based on data from the PRIME ‘203’ and ‘181’ clinical studies which demonstrated that Vectibix in combination with chemotherapy (FOLFOX or FOLFIRI) significantly improved progression-free survival in patients with wild-type KRAS tumors. The adverse event profiles in both trials were as expected for an anti-EGFR antibody treatment used in combination with these types of chemotherapy regimens.

Earlier this year, Amgen also submitted a variation application for first- and second-line use of Vectibix in combination with chemotherapy in patients with wild-type KRAS mCRC in the European Union with the Committee for Medicinal Products for Human Use (CHMP).