US FDA briefing documents on Novartis AG's tisagenlecleucel-T (CTL109) suggest the first advisory committee review of a CART-T therapy will focus more on product quality considerations, safety and risk mitigation measures than on clinical efficacy.
The Oncologic Drugs Advisory Committee will meet July 12 to consider tisagenlecleucel-T (formerly CTL109) for the treatment of pediatric and young adult patients ages three to 25 years old