Posted by Michael Wonder on 18 Apr 2017
Novartis CAR-T cell therapy CTL019 receives FDA breakthrough therapy designation for treatment of adult patients with r/r DLBCL
18 April 2017 - Advances in CTL019 result from collaboration with the University of Pennsylvania; regulatory submissions for relapsed and refractory diffuse large B-cell lymphoma expected to be filed by the end of the year.
Novartis announced today that the US FDA has granted breakthrough therapy designation to CTL019, an investigational chimeric antigen receptor T cell therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma, who have failed two or more prior therapies.
This is the second indication for which CTL019 has received this designation; the first being for the treatment of r/r B-cell acute lymphoblastic leukaemia in paediatric and young adult patients.
