Carl June, MD
The FDA has granted a breakthrough therapy designation to tisagenlecleucel-T (CTL019) for use as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after the failure of at least 2 prior therapies, according to Novartis, the developer of the CAR T-cell therapy.
The CR rate was 68% with tisagenlecleucel-T, and 14% of patients had a CRi. All patients with a CR/CRi also tested negative for minimal residual disease (95% CI, 69-91; P
Forty-four patients continue to be followed in the study at the time of the assessment. Eighteen discontinued follow-up due to deaths (n = 6), relapse (n = 5), starting a new therapy while in CR (n = 5), and patient or guardian decision (n = 2). There were 2 deaths within 30 days of treatment (1 from ALL and 1 from cerebral hemorrhage). There were no deaths related to cytokine release syndrome (CRS) and no cases of cerebral edema were reported.
... to read the full story