07 May FDA fast-tracks therapy for radiation-induced dry mouth

UW School of Medicine and Public Health

A therapy under development at the University of Wisconsin School of Medicine and Public Health to treat a common side effect of radiation therapy recently got a boost from the Food and Drug Administration.

The novel cell therapy, designed to treat xerostomia, commonly called dry mouth, caused by radiation therapy, was granted Fast Track designation by the federal agency. The therapy, currently in a Phase 1 clinical trial at the UW Health | Carbone Cancer Center, was developed by the Program for Advanced Cell Therapy, a partnership between UW Health and the UW School of Medicine and Public Health.

Fast Track designation speeds up the review process for drugs and devices, which can take 10 years or more, as they go through the FDA approval process. It is granted to therapies that treat serious conditions and fill unmet medical needs. Read more…