The US Food and Drug Administration (FDA) has approved Novartis’ CTL019 (tisagenlecleucel-T), an investigational CAR-T therapy designed to treat patients with relapsed and refractory B-cell acute lymphoblastic leukemia. The therapy will be marketed as Kymriah.
A 10-member expert panel convened by the FDA had unanimously voted in favor of this CAR T therapy in July 2017. Dr Tim Cripe, an oncologist who was part of the FDA advisory committee panel that voted in favor of the approval commented: “I think this is most exciting thing I’ve seen in my lifetime.”
CTL019 was first developed by the University of Pennsylvania (UPenn) and in 2012, Novartis entered a strategic license agreement with UPenn to further research, development and commercialization of CAR-T therapies.
The most important question now is the price of the therapy. Although Novartis hasn’t disclosed how much it intends to charge for Kymriah, experts predict it could cost as much as $700,000 for a course of treatment.
The FDA is also expected to make a decision about another CAR-T treatment from Kite Pharma, which was just acquired by Gilead Sciences, for treating aggressive B-cell non-Hodgkin lymphoma.
Source: Novartis crosses the FDA finish line with monumental CAR-T leukemia approval; Press Release