Novartis: CTL019 receives innovative treatment status.

(CercleFinance.com) - Swiss pharmaceutical group Novartis announced on Tuesday that the FDA has granted Breakthrough Therapy designation to CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy.


This is for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies.

This status as an innovative treatment means that the FDA will accelerate the development and review of CTL019. It was granted on the basis of data from the JULIET Phase II study.


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