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 Belen 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."
In the updated product information, Erbitux will now be indicated for the treatment of patients with EGFR-expressing, RAS wild-type mCRC in combination with irinotecan-based chemotherapy, in 1st line in combination with FOLFOX, or as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. In this label change, the existing contraindication for the combination of Erbitux with oxaliplatin-containing chemotherapy is now extended to include patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.
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