FDA approves Vectibix plus FOLFOX for first line Colorectal Cancer treatment - Amgen

The FDA has approved Vectibix (panitumumab), from Amgen, for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS (exon 2) metastatic Colorectal Cancer (mCRC). Vectibix becomes the first and only biologic to offer a significant survival benefit as a first-line treatment with FOLFOX, one of the most commonly used chemotherapy regimens in the first-line setting for patients with wild-type KRAS mCRC. In addition, this approval converts the accelerated monotherapy approval to a full approval for Vectibix.

The approval is based on results from Amgen�s PRIME (�203) and ASPECCT (�763) trials. The PRIME Phase III study showed that patients with wild-type KRAS tumors in exon 2 achieved statistically significant improvement in progression-free survival (PFS) with Vectibix and FOLFOX versus FOLFOX alone (9.6 versus 8.0 months) and a significant 4.4 month improvement in overall survival (OS) versus FOLFOX alone (23.8 versus 19.4 months). The Phase III ASPECCT study met its primary endpoint of non-inferiority for improving overall survival in patients taking Vectibix versus Erbitux.