As the US partners for Erbitux (Bristol-Myers Squibb and ImClone Systems) carry on with their stand-off, the European licensee for the drug, Merck KGaA is looking to get approval for a new indication of the oncology agent.

The German firm says that its Merck Serono division has submitted an application to the European Medicines Agency to license Erbitux (cetuximab) for the first-line treatment of epidermal growth
factor receptor expressing, advanced or metastatic non-small cell lung cancer.

The submission is supported by data from the Phase III FLEX study presented this year at the American Society of Clinical Oncology meeting this year. That study demonstrated a significant increase in overall survival for patients receiving Erbitux in combination with a platinum-based chemotherapy as a first-line treatment for advanced NSCLC.

Wolfgang Wein, executive vice president of oncology at Merck Serono, said that “Erbitux represents the first significant and clinically relevant advance in 10 years in the treatment of such a broad patient population in NSCLC.” If approved, it will be “a new important option for the therapy of this aggressive and difficult-to-treat cancer”.

Erbitux is already licensed in the European Union for all lines of treatment for patients with EGFR-expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy, and as a single agent for patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to the latter. The drug is also approved for use in combination with radiotherapy for locally advanced squamous cell carcinoma of the head and neck.

In addition, Merck Serono submitted an application to the EMEA in June 2008 to broaden the use of Erbitux to include first-line treatment of recurrent and/or metastatic SCCHN.