Kymriah
An intravenous gene-modified cellular immunotherapy for leukemia and lymphoma.
Where Tisagenlecleucel is approved
All regulators →Of the three regulators tracked here, the first to approve Tisagenlecleucel was the EU, on 23 Aug 2018. It is approved in 2 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of follicular lymphoma (19 Jul 2021, positive)
- 1 EU safety letter (DHPC), latest: adverse event for Abecma / Breyanzi / Carvykti / Kymriah / Tecartus / Yescarta, 18 Jul 2024
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Tisagenlecleucel patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tisagenlecleucel, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Kymriah for treatment of B-lymphoblastic leukaemia/lymphoma: until 27 Aug 2028. Union Register
- Kymriah for treatment of diffuse large B-cell lymphoma: until 27 Aug 2028. Union Register
- Kymriah for treatment of follicular lymphoma: until 3 May 2032. Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 12 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How Tisagenlecleucel works
All drug targets →- B-lymphocyte antigen CD19 binding agent Binding agentTarget: CD19 CD19 moleculeChEMBL only
- Acute lymphoblastic leukemiaPhase 3
- Follicular lymphomaPhase 3
- High grade B-cell lymphomaPhase 3
- Non-Hodgkin lymphomaPhase 3
- Burkitt lymphomaPhase 2
- Hematopoietic and lymphoid cell neoplasmPhase 2
- Mantle cell lymphomaPhase 2
- B-cell acute lymphoblastic leukemiaPhase 1
- B-cell chronic lymphocytic leukemiaPhase 1
- B-cell non-Hodgkin lymphomaPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3301574, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Tisagenlecleucel
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Tisagenlecleucel. 3 are current, and 1 of these recommend it for at least some patients. 2 older appraisals were replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Tisagenlecleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people 25 years and under NICE TA975 | Recommended | 15 May 2024 | Current |
| Tisagenlecleucel for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies (terminated appraisal) NICE TA933 | Terminated (no company submission) | 29 Nov 2023 | Current |
| Tisagenlecleucel for treating follicular lymphoma after 2 or more therapies (terminated appraisal) NICE TA842 | Terminated (no company submission) | 22 Nov 2022 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Tisagenlecleucel
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- EUEuropean Union: KymriahEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
What Kymriah is used for
KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. ( 1.1 ) Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Limitations of Use : KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma. ( 1.2 ) Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication…
How it works
12.1 Mechanism of Action KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells. The CAR is comprised of a murine single-chain antibody fragment which recognizes CD19 and is fused to intracellular signaling domains from 4-1BB (CD137) and CD3 zeta. The CD3 zeta component is critical for initiating T cell activation and antitumor activity, while 4-1BB enhances the expansion and persistence of KYMRIAH. Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T cell expan…
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 12 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.