Merck Serono, the biopharmaceutical division of Merck, has 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 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 Erbitux, 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 Erbitux, while patients with RAS mutant tumours 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.”
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.
The full Erbitux patient information will be publicly available in the revised SmPC. Once updated, this will be available online at www.ema.europa.eu/ema
- Tejpar S, et al. Accepted at 2014 Gastrointestinal Cancers Symposium, January 16–18, 2014.