Panitumumab-with FOLFOX Approved for mCRC Patients with WT KRas

Vectibix is the First and Only Biologic to Offer Significant Survival Benefit as a First-Line Treatment with FOLFOX Chemotherapy for Patients with Wild-Type KRAS Metastatic Colorectal Cancer Approval Reinforces Amgen Commitment to Personalized Medicine.

Amgen

today announced that the U.S.

Food and Drug Administration

(FDA) has approved Vectibix® (panitumumab) 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). With this approval, 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. FDA also approved the therascreen®KRAS RGQ PCR Kit developed by QIAGEN (therascreenKRAS test) as a companion diagnostic for Vectibix.

Original report:

http://on.mktw.net/1mkAmiG

Source: MarketWatch