USA-based Amgen (Nasdaq: AMGN), the world's leading independent biotech firm, has announced that the US Food and Drug Administration has approved Vectibix (panitumumab) for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-typeKRAS (exon 2) metastatic colorectal cancer (mCRC).
The approval means Vectibix becomes the first 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. It also converts the accelerated monotherapy approval to a full approval for Vectibix. The FDA also approved the therascreen KRAS RGQ PCR Kit developed by biotech company Qiagen (therascreen KRAS test) as a companion diagnostic for Vectibix. Amgen also said the approval was a milestone in its biomarker research which helps personalize cancer treatment.
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