European Commission approves update of Erbitux metastatic colorectal cancer labeling to patients with RAS wild-type tumors

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 tumor 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, 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."

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.

About the OPUS Study

OPUS is a randomized, controlled, Phase II trial, involving 337 mCRC patients, 179 with KRAS wild-type (exon 2) tumors, demonstrating the efficacy of Erbitux plus FOLFOX-4 (oxaliplatin-based therapy) versus FOLFOX-4 alone.² Results of a RAS tumor status analysis will be presented at Gastrointestinal Cancers Symposium (ASCO GI) in January 2014, in San Francisco, California, U.S.

About Colorectal Cancer

Colorectal cancer (CRC) is the fourth most common cancer worldwide, with an estimated incidence of more than 1.2 million cases globally.³ An estimated 608,000 deaths from CRC occur worldwide each year, accounting for 8% of all cancer deaths and making it the fourth most common cause of death from cancer.3 Almost 60% of the cases occur in developed regions, and incidence and mortality rates are substantially higher in men than in women.³ In Europe alone, an estimated 436,000 people develop CRC every year, with approximately 212,000 people dying from the disease annually.⁴