FDA expands label for Amgen's Vectibix

FDA approved Vectibix panitumumab from Amgen Inc. (NASDAQ:AMGN) for use in combination with FOLFOX chemotherapy as first-line treatment of metastatic colorectal cancer (mCRC) in patients with wild-type K-Ras (KRAS) tumors. Amgen said the approval also covers full approval for Vectibix as monotherapy to treat EGFR-expressing mCRC in patients who progressed after chemotherapy; FDA granted accelerated approval for the monotherapy indication in 2006. Vectibix is a human mAb against epidermal growth factor receptor 1 ( EGFR1; HER1; ErbB1).

Additionally, FDA approved a PMA from Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN) for therascreen KRAS RGQ PCR Kit as a companion diagnostic for Vectibix. The PCR-based test is also approved in the U.S. as a companion diagnostic for Erbitux, from the ImClone Systems Inc. subsidiary of Eli Lilly and Co. (NYSE:LLY) and Merck KGaA (Xetra:MRK). ...