Merck Withdraws European Filing for Erbitux in NSCLC
Merck announced the strategic decision to voluntarily withdraw the marketing authorization application (MAA) to the European Medicines Agency (EMA) of a label extension for Erbitux® (cetuximab) in combination with standard first-line platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression. The decision to withdraw the application was based on feedback from European regulatory authorities, indicating that further data would be required. The decision does not alter the proven utility of Erbitux in its already approved indications in metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN).
“We are disappointed that we have not been able to move forward with the filing in NSCLC but it has become apparent that further data will be required to support the clinical utility of Erbitux in this specific population,” said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for the Merck Serono division. “We continue to advance our oncology pipeline, for example also by planning to initiate a randomized Phase III trial of TH-302 in patients with advanced first-line pancreatic cancer together with our partner Threshold.”
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