The FDA has approved revisions to the prescribing information of Vectibix (panitumumab, from Amgen), a human epidermal growth factor receptor (EGFr) inhibitor. This decision follows FDA’s December 2008 Oncologics Drugs Advisory Committee meeting where the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-EGFr antibody was discussed. The INDICATION AND USAGE section of the Vectibix prescribing information has been updated to include that retrospective subset analyses of mCRC trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. The CLINICAL STUDIES section of the prescribing information has been updated to reflect results from retrospective analyses across seven randomized clinical trials with agents in this class, including Phase 3 analysis that showed mCRC patients with mutated KRAS tumors do not respond to monotherapy with an EGFr-inhibiting antibody. This label update is specific to the utility of KRAS as a biomarker for Vectibix used as a monotherapy. In the combination chemotherapy setting, data from clinical studies of Vectibix are expected in the third quarter of 2009.

Vectibix is indicated as a single agent for the treatment of EGFR-expressing mCRC with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

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