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# Priority Review for Novartis sBLA for Kymriah
- URL: https://www.fdaweb.com/priority-review-for-novartis-sbla-for-kymriah/
- Published: 2018-01-17T12:00:00.000Z
- Updated: 2026-09-14T23:14:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140526

FDA has accepted for priority review a Novartis supplemental BLA for Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for, or relapse after, autologous stem cell transplant. Kymriah was the first CAR-T cell therapy to receive regulatory approval 8/2017 when it gained approval for treating patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse. The immunocellular therapy uses a patient’s own T cells to fight cancer.

The submission is based on data from the pivotal Phase 2 JULIET clinical trial. The company says it plans additional regulatory submissions for Kymriah in pediatric and young adult patients this year.