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The European Medicines Agency (EMEA) is to review a drug targeted at the treatment of recurrent cancer of the head and neck.
Advexin is designed to restore the tumour suppressing gene p53 that is blocked in the majority of tumours. If approved, it will be the first gene therapy product approved for use in Europe.
“This acceptance of the Advexin Marketing Authorisation Application (MAA) by the EMEA marks an historic point in the growth of personalised medicine, and the treatment of head and neck cancer,” said Max Talbott, senior vice president of worldwide commercial development at the drug’s developer, Introgen Therapeutics.
“This action by the EMEA underscores the rapidly increasing importance of biomarkers, in the development and regulatory approval processes for targeted therapeutics. We look forward to working with the EMEA during the Advexin review process, which we hope will lead to the first gene therapy product in Europe.”
The MAA follows a phase III study of Advexin in patients with recurrent, refractory squamous cell carcinoma of the head and neck. It successfully achieved its goal, which was survival or tumour response in patients.
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