On Tuesday, German pharmaceuticals maker Merck KGaA is withdrawing its application for its drug Erbitux used to treat patients with lung cancer.
Merck said in a statement it had decided to "voluntarily withdraw the marketing authorisation application to the European Medicines Agency" for Erbitux to be used to treat patients with advanced or metastatic non-small cell lung cancer.
AdvertisementThe decision was "based on feedback from European regulatory authorities, indicating that further data would be required," the statement said.
It would not affect, however, "the proven utility of Erbitux in its already approved indications in metastatic colorectal cancer and head and neck cancer," Merck insisted.
"We are disappointed that we have not been able to move forward with the filing but it has become apparent that further data will be required to support the clinical utility of Erbitux in this specific population," said Merck's head of drug development, Annalisa Jenkins.
Already in July, Merck KGaA had said that phase III clinical trials of Erbitux for treatment of gastric cancer drug had shown no benefits of the drug for patients.
The news hit Merck KGaA shares which were showing a loss of 1.24 percent at 93.67 euros in mid-morning trade on the Frankfurt stock exchange in a generally softer market.
You May Also Like