Yescarta
An intravenous gene-modified cellular therapy for certain types of advanced lymphoma.
Where Axicabtagene Ciloleucel is approved
All regulators →Of the three regulators tracked here, the first to approve Axicabtagene Ciloleucel 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 marginal zone lymphoma (26 Jun 2020, 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.
Axicabtagene Ciloleucel patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Axicabtagene Ciloleucel, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Yescarta for treatment of diffuse large B cell lymphoma: until 27 Aug 2028. Union Register
- Yescarta for treatment of primary mediastinal large B-cell lymphoma: until 27 Aug 2028. Union Register
- Yescarta for treatment of follicular lymphoma: until 23 Jun 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.
What health systems spend on Axicabtagene Ciloleucel
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Axicabtagene Ciloleucel works
All drug targets →- B-lymphocyte antigen CD19 binding agent Binding agentTarget: CD19 CD19 moleculeChEMBL only
- Mantle cell lymphomaPhase 2/3
- Hematopoietic and lymphoid cell neoplasmPhase 2
- LymphomaPhase 2
- Non-Hodgkin lymphomaPhase 2
- B-cell non-Hodgkin lymphomaPhase 1/2
- Primary central nervous system lymphomaPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3989989, 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 Axicabtagene Ciloleucel
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Axicabtagene Ciloleucel. 4 are current, and 1 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Axicabtagene ciloleucel for treating relapsed or refractory follicular lymphoma NICE TA894 | Not recommended | 7 Jun 2023 | Current |
| Axicabtagene ciloleucel for treating relapsed or refractory diffuse large B-cell lymphoma after first-line chemoimmunotherapy NICE TA895 | Recommended (Cancer Drugs Fund) | 7 Jun 2023 | Current |
| Axicabtagene ciloleucel for treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies NICE TA872 | Recommended | 28 Feb 2023 | Current |
| Axicabtagene ciloleucel for treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies NICE TA559 | Recommended (Cancer Drugs Fund) | 23 Jan 2019 | 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 Axicabtagene Ciloleucel
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: YescartaEMA 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 Yescarta is used for
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. ( 1.1 ) Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. ( 1.1 ) 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in conf…
How it works
12.1 Mechanism of Action YESCARTA, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.
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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.