Potential First U.S. Gene Therapy Now Under FDA Review

Share this content:
Potential First U.S. Gene Therapy Now Under FDA Review
Potential First U.S. Gene Therapy Now Under FDA Review

THURSDAY, July 13, 2017 (HealthDay News) -- The potential first gene therapy in the United States is being reviewed by a U.S. Food and Drug Administration expert panel.

At the Wednesday meeting, the panel will assess the safety, effectiveness, and production of the one-time treatment for children and young adults with advanced leukemia, the Associated Press reported.

The experimental gene therapy drug was developed by the University of Pennsylvania and Novartis and is called tisagenlecleucel (CTL019). It involves reprogramming a patient's own T cells with a transgene encoding a chimeric antigen receptor to identify and eliminate CD19-expressing malignant and non-malignant cells.

After reviewing the data, the panel will vote on whether to recommend FDA approval, the AP reported.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

Ground Beef Recalled After E. Coli Outbreak

Ground Beef Recalled After <i>E. Coli</i> Outbreak

Beef was produced and packaged at Cargill Meat Solutions in Fort Morgan, Colo.

Prevalence of Alzheimer's, Related Dementia Set to Double

Prevalence of Alzheimer's, Related Dementia Set to Double

Alzheimer's disease and related dementias burden is expected to increase to 3.3 percent in 2060

Long-Term Outcomes of Breast Implants Explored

Long-Term Outcomes of Breast Implants Explored

Higher rates of Sjogren syndrome, scleroderma, RA, stillbirth, melanoma for silicone implants

is free, fast, and customized just for you!




Already a member?

Sign In Now »