German pharmaceuticals company Merck KGaA (MKGAY.PK) Tuesday announced that it has decided to voluntarily withdraw European filing for its cancer drug Erbitux (cetuximab), as the regulatory authorities required further data to support the drug's clinical utility.
The filing was related to a label extension for Erbitux in combination with standard first-line platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer, or NSCLC, with high epidermal growth factor receptor, or EGFR, expression.
The company said its decision to withdraw the marketing authorization application, or MAA, to the European Medicines Agency was based on a feedback from the regulatory authorities.
"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 Annalisa Jenkins, head of Global Drug Development and Medical for the Merck Serono division.
Erbitux is already approved to be used alone or with other drugs to treat colorectal cancer and certain head and neck cancers. The firm noted that the use of Erbitux in its already approved indications will not be affected by this decision.
Erbitux has already obtained marketing authorization in 92 countries for treating colorectal cancer and in 89 countries for treating squamous cell carcinoma of the head and neck.
Merck KGaA has licensed the right to market Erbitux outside the U.S. and Canada from ImClone LLC - a unit of Eli Lilly and Co. (LLY), in 1998.
"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," Jenkins added.
On September 17, Threshold Pharmaceuticals, Inc., announced that data from a randomized open-label Phase IIb clinical trial of investigational hypoxia-targeted drug TH-302 will be presented at the European Society for Medical Oncology (ESMO) 2012 Congress in Vienna during September 28 to October 2.
In early July, Merck had said Erbitux failed to meet primary goal of progression-free survival in a late-stage trial in patients with advanced gastric cancer.
On Frankfurt's Xetra, Merck shares are currently trading at 93.7 euros, down 1.05 euros or 1.21 percent, on a volume of 178 thousand shares.
by RTT Staff Writer
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