Vectibix gets conditional approval in Europe

The EC granted conditional marketing approval to Vectibix panitumumab from Amgen (AMGN) for use as monotherapy to treat EGFR-expressing metastatic colorectal cancer with wild-type K-Ras (KRAS) genes after failure of standard chemotherapy. AMGN recently convinced EMEA's CHMP to reverse a negative opinion on Vectibix based in part on biomarker data from a Phase III trial that showed how to focus use of the drug in patients for whom it works. The company confirmed that efficacy of the anti- EGFR antibody was confined to the subset of metastatic colorectal cancer patients with wild-type K-Ras gene expression (See BioCentury, Oct. 08, 2007). ...