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  3. KYMRIAH®▼ (tisagenlecleucel)

Prescribing information

 

Kymriah® (tisagenlecleucel)

   

Kymriah® is indicated for the treatment of paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, and adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.1

For CAR-T patients, we must look at the overall treatment experience

 

animated circular images with moving around outside. Text on circle is Survival and treatment response
  • 2-year PFS rate of 33%2
  • High (60%) relapse-free survival at 24 months3
  • Supportive outcome data emerging in RWE4,5

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animated circular images with moving around outside. Text on circle is Real-world quality of life
  • Low rates of CRS (1–4.5%) & neurotoxicity (0–1%) in the real world4,5
  • QoL improvements6

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animated circular images with moving around outside. Text on circle is Convenience of administration
  • Simple, 1-time infusion1
  • Outpatient/inpatient1,5
  • Benefits of cryopreservation7

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animated circular images with moving around outside. Text on circle is Manufacturing commitment
  • 7 manufacturing sites worldwide8
  • Commitment to no queue

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CAR-T, chimeric antigen receptors cell therapy; CRS, cytokine release syndrome; PFS, progression-free survival; QoL, quality of life.

Reference

  1. Kymriah Summary of Product Characteristics; Novartis Pharmaceuticals UK Ltd.
  2. Jaeger U et al. Poster presented at the 2021 Transplantation and Cellular Therapy Annual Meeting, held virtually on 8–12 February 2021. Poster 212.
  3. Jaeger U et al. Poster presented at the 2020 ASH Annual Meeting & Exposition, held virtually on 5–8 December 2020. Poster 1194.
  4. Pasquini MC et al. Blood Adv. 2020; 4(21): 5414–5424.
  5. Riedell P et al. Transplantation & Cellular Therapy Annual Meeting; February 19-23, 2020; Orlando, FL. Presentation 52.
  6. Maziarz RT et al. Blood Adv. 2020;4:629–37.
  7. Data on file. Novartis CTL019 leukapheresis reference manual: leukapheresis collection. Novartis Pharmaceuticals Corp; 2016.
  8. Pharmatech. Available at: https://www.pharmtech.com/view/novartis-gets-ema-approval-for-two-europe... [Accessed December 2021].
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UK | October 2021 | 144093
Haematology
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]