New type of gene-therapy drug submitted to FDA

AUSTIN, Texas & DUBLIN, Ireland Recurrent refractory head and neck cancers could become easier to treat thanks a new drug under consideration for approval by the Food and Drug Administration.

Austin, Texas-based Introgen Therapeutics submitted an application to the FDA for Advexin, a gene therapy drug designed to treat cancers difficult to treat with other drugs. Introgen has been working on Advexin for 14 years, and is the first drug of its kind to be submitted for approval.

The drug inserts the body’s tumor-suppressing p53 gene into tumors in order to strengthen the body’s ability to defend against them.

Introgen’s Ireland-based subsidiary, Gendux Molecular, also submitted an application to the European Medicines Evaluation Agency.