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news.Introgen Therapeutics and its subsidiary Gendux Molecular have reported that their marketing authorization application for Advexin has now been accepted for technical review by the European medicines regulatory authority, the EMEA, for the treatment of inherited Li-Fraumeni Syndrome cancers.
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This acceptance indicates that all administrative issues have been addressed and that the formal technical evaluation of the application will be conducted under the EMEA’s exceptional circumstances approval rules. Introgen said that if approved, Advexin will be the world’s first treatment specific for an inherited cancer syndrome.
The acceptance of the marketing authorization application (MAA) for Advexin will initiate the regulatory review of the application’s preclinical, manufacturing and clinical data by EMEA. The review will be based on clinical efficacy and safety results from the use of Advexin in Li-Fraumeni Syndrome and in a variety of non-inherited cancers with abnormal p53 tumor suppression that is the target of Advexin treatment.
Max Talbott, senior vice president of worldwide regulatory affairs, said: “We are encouraged by the EMEA’s acceptance of our application under the exceptional circumstances approval provisions and now look forward to working with the European regulatory authorities during the technical review process.”