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Novartis Submits sBLA for Tisagenlecleucel in Adults With Relapsed/Refractory DLBCL

Jason Harris
Published: Tuesday, Oct 31, 2017

Dr Stephen J. Schuster
Stephen J. Schuster, MD
Novartis has filed a supplemental biologics license application (sBLA) with the FDA to expand the indication for tisagenlecleucel (Kymriah) to include adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).

DLBCL is the most common form of non-Hodgkin lymphoma (NHL) that accounts for up to 40% of all cases worldwide. Approximately 50% to 60% of patients with DLBCL achieve and maintain complete remission after frontline therapy, but approximately one-third of patients relapse after receiving first-line treatment. Furthermore, only 25% of patients with relapsed/refractory DLBCL are eligible for ASCT, which is a standard secondary treatment. Untreated relapsed/refractory DLBCL has a life expectancy of 3 to 4 months.
Schuster SJ, Bishop MR, Tam, et al. Global pivotal phase 2 trial of the cd19-targeted therapy ctl019 in adult patients with relapsed or refractory (r/r) diffuse large b-cell lymphoma (DLBCL)—an interim analysis [published online ahead of print June 7, 2017]. Hematol Oncol. 2017,35(suppl S2).

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