Erbitux cetuximab regulatory update

FDA simultaneously approved a label expansion for Erbitux cetuximab to include first-line therapy for metastatic colorectal cancer (mCRC) and a companion diagnostic from Qiagen for use with the drug. Erbitux's label now includes first-line use in combination with FOLFIRI chemotherapy in mCRC patients with EGFR-expressing, K-Ras wild-type tumors. Qiagen's companion diagnostic, therascreen KRAS RGQ PCR Kit, is a PCR-based test that detects mutations in codons 12 and 13 of the K-Ras gene to predict patient response to Erbitux. ...