FDA approves first gene therapy – tisagenlecleucel for ALL

At its meeting in July, the FDA ODAC agreed nearly unanimously that the risk mitigation plan put forward by Novartis, including planned 15-year follow-up and other mitigation measures, would be adequate for detecting serious consequences of CAR T-cell therapy.

sworcester@frontlinemedcom.com

This article was updated August 30, 2017.