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FDA Approves Qiagen CDx for Vectibix Colorectal Cancer Drug

NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Qiagen's Therascreen KRAS RGQ PCR companion test to pick out best responders to Amgen's colorectal cancer drug Vectibix (panitumumab).

Simultaneously, the agency also approved late last week Vectibix in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, for first-line treatment of patients with wild-type KRAS metastatic colorectal cancer. The latest approval converts the accelerated approval for Vectibix into full approval.

The approval of the Therascreen KRAS test for Vectibix comes after the FDA cleared the same platform in 2012 to gauge best responders to Bristol-Myers Squibb/Eli Lilly's Erbitux (cetuximab), a drug in the same class. Last year, the agency approved Qiagen's Therascreen EGFR RGQ PCR Kit to guide treatment decisions with Boehringer Ingelheim's Gilotrif (afatinib).

In Europe, Qiagen markets Therascreen assays for biomarkers including KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT, and UGT1A1, and sells various companion tests in China and Japan.