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# Novartis sBLA for Kymriah in Lymphoma Patients
- URL: https://www.fdaweb.com/novartis-sbla-for-kymriah-in-lymphoma-patients/
- Published: 2017-11-01T12:00:00.000Z
- Updated: 2026-09-14T22:59:20.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5140030

Novartis has submitted a supplemental BLA for Kymriah (tisagenlecleucel) suspension for intravenous infusion for treating adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. In August, Kymriah became the first available chimeric antigen receptor T (CAR-T) cell therapy when it received FDA approval for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or has relapsed at least twice. Kymriah is an immunocellular therapy that uses a patient’s own T cells to fight cancer.  
  
The submission is based on results from the Novartis-sponsored Phase 2 JULIET study, which the company describes as the largest study examining a CAR-T therapy exclusively in DLBCL, enrolling patients from 27 sites in 10 countries across the U.S., Canada, Europe, Australia and Japan. Data from the six-month primary analysis will be presented at the American Society of Hematology annual meeting next month.