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December 23, 2013 /PRNewswire/ --
The European Commission's approval is based on the CHMP positive opinion
Label update comes in response to new biomarker data obtained from the OPUS study
Merck Serono, the biopharmaceutical division of Merck, today announced that the European Commission has approved the Type II variation to amend the Erbitux
® (cetuximab) product information, updating the indication for Erbitux to the treatment of patients with RAS wild-type metastatic colorectal cancer (mCRC). The approval of the European Commission follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) (issued in
November 2013) and is based on the totality of data emerging on the role of mCRC RAS tumor status in the benefit-risk profile of the drug. The approval primarily refers to new biomarker data from the OPUS (
Platin and cet
Uximab in fir
St-line treatment of mCRC) study.
In recent analyses of studies evaluating monoclonal anti-epidermal growth factor receptor (EGFR) antibodies, such as Erbitux, tumor samples of patients with KRAS wild-type tumor status (exon 2) were assessed for additional RAS mutations (defined as mutations in exons 3 or 4 of KRAS and/or exons 2, 3 or 4 of NRAS). The results from these studies suggest that patients with RAS wild-type tumors may benefit from treatment with Erbitux, while patients with RAS mutant tumors may not.
"We fully endorse the update to the indication of Erbitux in metastatic colorectal cancer, as it will provide further guidance to physicians who manage patients with colorectal cancer," said Belén Garijo, President and CEO of Merck Serono. "We will now be working with the regulatory agencies to effectively communicate the implications of this label change to healthcare professionals and patients."