Introgen's Advexin Application Accepted for Review

The European Medicines Agency has accepted the Advexin marketing authorization application for technical review.

Advexin is made by Introgen Therapeutics and its Irish subsidiary Gendux Molecular for the treatment of inherited Li-Fraumeni Syndrome (LFS) cancers.

The review will be based on clinical efficacy and safety results of trials in LFS and a variety of noninherited cancers with abnormal p53 tumor suppression.

If approved, Advexin would be the world’s first treatment for an inherited cancer syndrome, Introgen said.