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Merck withdraws EU filing for Erbitux in lung cancer

Follows request from EMA for more data

Merck's Erbitux

Merck KGaA has decided to withdraw its marketing application for Erbitux in non-small cell lung cancer (NSCLC) in the EU after receiving feedback from the European Medicines Agency (EMA).

The company had submitted Erbitux (cetuximab) for use alongside standard first-line platinum-based chemotherapy in patients with advanced or metastatic NSCLC who had high levels of epidermal growth factor receptor (EGFR) expression, but says it will have to provide additional supporting data to the EMA.

Merck already sells Erbitux as a treatment for metastatic colorectal cancer and squamous cell carcinoma of the head and neck, bringing in €430m in the first six months of 2012, but has struggled to expand its uses into other applications.

The company decided recently not to pursue development of Erbitux in gastric cancer and as an adjuvant therapy for colon cancer, although on a more positive note, the drug was accepted for priority review in Japan earlier this year as a treatment for head and neck cancer and has also been filed for that indication in China.

"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," commented Dr Annalisa Jenkins, Merck's head of global drug development.

Jenkins said that company is now focusing on candidate pancreatic cancer drug TH-302 in its oncology pipeline, with new phase IIb data presented yesterday indicating that it achieved a 63 per cent improvement in progression-free survival (PFS) when added onto gemcitabine therapy.

TH-302 - a hypoxia-targeted alkylating agent licensed from Threshold Pharmaceuticals - also improved overall survival in the study although this did not reach statistical significance, said Merck. The data will be presented at the European Society for Medical Oncology (ESMO) 2012 Congress in Vienna later this month.

The company now intends to press on with a phase III trial of the drug candidate in patients with advanced first-line pancreatic cancer, according to Jenkins.

18th September 2012

From: Research, Regulatory

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