Novartis investigational CAR-T therapy gets FDA priority review

Novartis’ investigational chimeric antigen receptor T cell (CAR-T) therapy CTL019 (tisagenlecleucel-T) has been awarded has been awarded priority review by the FDA for the treatment of relapsed and refractory B-cell acute lymphoblastic leukaemia (ALL) in pediatric and young adult patients, the company has announced.

This is the first CAR-T therapy submission for Novartis, and the news puts it ahead of closest rival Kite Pharma.

82% of patients administered with CTL019 showed complete remission either with or without incomplete blood count recovery within three months in a recent Phase 2 trial, with an estimated 60% relapse-free after six months. CAR-T therapies function through the alteration of a patient’s own T-cells, which are then integrated back into the body to target and destroy cancer cells.

Novartis expects that the treatment could generate revenues in excess of $1 billion once it hits the market.  

"With CTL019, Novartis is at the forefront of the science and development of immunocellular therapy as a potential new innovative approach to treating certain cancers where there are limited options," remarked Vas Narasimhan, Novartis Head of Drug Development.