With the approval, Vectibix becomes the first and only biologic to provide a significant survival benefit as a first-line treatment with FOLFOX for patients with wild-type KRAS mCRC.
Additionally, the approval converts the accelerated monotherapy approval to a full approval for Vectibix.
The FDA has also approved the therascreen KRAS RGQ PCR Kit developed by QIAGEN (therascreen KRAS test) as a companion diagnostic for Vectibix.
Amgen executive vice president of Research and Development Sean Harper said because every patient with cancer is unique, the company has made it their mission to focus on identifying treatment options for patients based on their cancer’s genetic makeup.
"Approval of Vectibix in combination with FOLFOX for first-line treatment of patients with wild-type KRAS metastatic colorectal cancer is an example of the advancements that can be made through a greater understanding of distinct genetic markers associated with difficult-to-treat diseases," Harper said.
The FDA approval is based on results from the company’s PRIME (‘203) and ASPECCT (‘763) trials.
The PRIME Phase III trial 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 and a significant 4.4 month improvement in overall survival (OS) versus FOLFOX alone.
The company said that the Phase III ASPECCT trial met its primary endpoint of non-inferiority for improving overall survival in patients taking Vectibix versus Erbitux (cetuximab) as a single agent for the treatment of mCRC in patients with wild-type KRAS tumors who have not responded to chemotherapy.