Gendux Molecular Limited withdraws its marketing authorisation application for Advexin (contusugene ladenovec)
The European Medicines Agency (EMEA) has been formally notified by Gendux Molecular Limited of its decision to withdraw its application for a centralised marketing authorisation for the medicinal product Advexin (contusugene ladenovec) suspension for injection.
Advexin was expected to be used for the treatment of Li-Fraumeni cancer in patients from the age of 18 years as monotherapy.
The application for marketing authorisation for Advexin was submitted to the EMEA on 6 September 2007. At the time of the withdrawal, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).
In its official letter, the company stated that the reason for the withdrawal of application for Advexin was based on the company's marketing strategy.
More information about Advexin and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.
- Withdrawal of an application does not prejudice the possibility of a company making a new application at a later stage.