Following up last year’s ground-breaking news that CAR T therapy Kymriah had become the first such treatment to be approved for the FDA – authorised for use in children and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL) – Novartis has revealed that its proposed label expansion has been accepted under accelerated regulatory pathways on both sides of the Atlantic.
Novartis’ CAR T therapy Kymriah scores accelerated approval in both Europe and US
