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Kymriah FDA Approval History

FDA Approved: Yes (First approved August 30, 2017)
Brand name: Kymriah
Generic name: tisagenlecleucel
Dosage form: Suspension for Intravenous Infusion
Previous Name: CTL019
Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Lymphoblastic Leukemia; Large B-Cell Lymphoma

Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for use in patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and patients with relapsed or refractory (r/r) large B-cell lymphoma.

Development Timeline for Kymriah

May  1, 2018Approval  Kymriah (tisagenlecleucel) Receives Second FDA Approval to Treat Appropriate Patients with Large B-Cell Lymphoma
Dec 10, 2017Primary Analysis Results from Novartis Pivotal JULIET Trial Show Kymriah (tisagenlecleucel) Sustained Complete Responses at Six Months in Adults with r/r DLBCL, a Difficult-to-Treat Cancer
Aug 30, 2017Approval  FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia
Jul 12, 2017Novartis CAR-T Cell Therapy CTL019 Unanimously (10-0) Recommended for Approval by FDA Advisory Committee to Treat Pediatric, Young Adult r/r B-Cell ALL
Apr 18, 2017Novartis CAR-T Cell Therapy CTL019 Receives FDA Breakthrough Therapy Designation for Treatment of Adult Patients with r/r DLBCL
Mar 29, 2017Novartis Announces First CAR-T Cell Therapy BLA for Pediatric and Young Adult Patients with r/r B-Cell ALL Granted FDA Priority Review

Further information

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