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news.Merck KGaA has announced that its Merck Serono division has submitted an application to the European Medicines Agency to license Erbitux for the firstline treatment of epidermal growth factor receptor expressing advanced or metastatic non-small cell lung cancer.
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The submission is supported by data from the Phase III Flex study which demonstrated a significant increase in overall survival for patients receiving Erbitux in combination with a platinum-based chemotherapy as a firstline treatment for advanced non-small cell lung cancer (NSCLC).
Wolfgang Wein, executive vice president of oncology at Merck Serono, said: “If approved in NSCLC Erbitux would not only provide physicians with a new important option for the therapy of this aggressive and difficult-to-treat cancer, it will also enable a greater number of cancer patients in Europe to benefit from treatment with Erbitux.”
Erbitux is already licensed in the EU for all lines of treatment for patients with epidermal growth factor receptor-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 irinotecan. Erbitux is also licensed in combination with radiotherapy for locally advanced squamous cell carcinoma of the head and neck.