The European Commission has approved the Type II variation to amend the cetuximab product information, updating the indication for cetuximab 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 tumour status in the benefit–risk profile of the drug. The approval primarily refers to new biomarker data from the OPUS (OxaliPlatin and cetUximab in firSt-line treatment of mCRC) study.1

In recent analyses of studies evaluating monoclonal anti-epidermal growth factor receptor (EGFR) antibodies, such as cetuximab, tumour samples of patients with KRAS wild-type tumour 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 tumours may benefit from treatment with cetuximab, while patients with RAS mutant tumours may not.

In the updated product information, cetuximab 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 cetuximab with oxaliplatin-containing chemotherapy is now extended to include patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.

The full cetuximab patient information will be publicly available in the revised SmPC. Once updated, this will be available online at www.ema.europa.eu/ema

Source: Merck-Serono