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FDA Grants CTL019 Breakthrough Designation for DLBCL

Jason M. Broderick @jasoncology
Published: Tuesday, Apr 18, 2017

Carl June, MD

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 <.0001).

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.
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