Prescribing information

 

   

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

  • Open-label, multicentre, single-arm, global study1
  • Primary endpoint: Overall response rate (ORR) [complete response (CR) + partial response (PR)]1  per independent review committee1
    • Adult patients with relapsed or refractory disease after ≥2 lines of chemotherapy, including rituximab and anthracycline, and either having failed  autologous HSCT, or being ineligible for or not consenting to autologous HSCT1,2
    • 167 patients enrolled; 115 patients were infused with tisagenlecleucel and evaluable for efficacy and safety with a median follow-up of 40.3 months3
  • Secondary endpoints: Included duration of response, overall survival, and safety1

JULIET study schematic3

Flow diagram for show JULIET study schematic.

*To be completed 2 to 14 days prior to Kymriah® infusion.
Infusion conducted on an inpatient or outpatient basis at investigator discretion.

Interact below to find out about the Phase 2 registration study establishing initial safety and efficacy in heavily pre-treated adult patients with R/R DLBCL1–3

Deep and durable responses

autoSCT, autologous stem cell transplant; CR, complete response; cy, cyclophosphamide; DLBCL, diffuse large B-cell lymphoma; DOR, duration of response; Flu, fludarabine; HSCT, haematopoietic stem-cell transplantation; LD, low-dose; LDC, low-dose chemotherapy; mo, month; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; R/R, relapsed and/or refractory.

References

  1. Kymriah (tisagenlecleucel) Summary of Product Characteristics; Novartis Pharmaceuticals UK Ltd.
  2. Schuster S, et al. N Engl J Med. 2019;380(1):45–56.
  3. Schuster S, et al. Abstract 626 presented at 60th ASH Annual Meeting, 2018, 1–4 December; San Diego, USA.
  4. Jaeger U, et al. Poster presented at the 2020 ASH Annual Meeting & Exposition, held virtually on 5–8 December 2020. Poster 1194.
  5. Pasquini MC, et al. Blood Adv. 2020;4(21):5414–5424.
  6. Riedell P, et al. Transplantation & Cellular Therapy Annual Meeting; February 19-23, 2020; Orlando, FL. Presentation 52.
  7. Jaeger U, et al. Poster presented at the 2021 Transplantation and Cellular Therapy Annual Meeting, held virtually on 8–12 February 2021. Poster 212.
  8. Andreadis C, et al. Poster presented at the 61st American Society of Hematology Annual Meeting; December 7–10, 2019; Orlando, FL. Poster 2883.
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UK | October 2021 | 144098
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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]