Novartis announced the submission of a supplemental Biologics License Application (sBLA) for Kymriah (tisagenlecleucel) suspension for intravenous (IV) infusion to the Food and Drug Administration (FDA) for its second indication.

Kymriah was approved in August 2017 as the first available chimeric antigen receptor T cell (CAR-T) therapy to treat patients aged ≤25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a one-time immunocellular therapy that uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence.

The latest sBLA is seeking approval to treat patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). The submission is based on results from the Phase 2 multicenter JULIET study that included patients from 27 sites in 10 different countries. 

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Stephen Schuster, MD, director of the Lymphoma Program and Lymphoma Translational Research, University of Pennsylvania Perelman School of Medicine, stated, “The data show this therapy could change the treatment paradigm for patients with r/r DLBCL as we’ve seen durable complete responses in patients who previously relapsed or were refractory to prior therapies, and this second filing is a significant step toward realizing its potential for even more patients who are currently battling fatal blood cancers.”

Six-month findings from JULIET’s primary analysis will be presented at the annual meeting of the American Society of Hematology (ASH) in December 2017. 

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