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

PLEASE NOTE that, due to differences between patient populations etc., direct comparisons cannot be made between clinical trial & real-world outcomes.

A manageable safety profile confirmed in real-world clinical practice vs the JULIET trial1–4

Cytokine release syndrome*

JULIET trial†1,2

22.6%

Grade 3/4

Median time to onset
3 days

Median duration
7 days

RWE

CIBMTR Registry3

4.5%

Grade 3/4

Median time to onset
4 days

Median duration
5 days

RWE

CAR T-Cell Consortium4

1%

Grade 3/4

Median time to onset
3 days

Median duration
3 days

 

Neurological events

JULIET trial†1,2

11.3%

Grade 3/4

Median time to onset
6 days

Median duration§
13 days

RWE

CIBMTR Registry3

5%

Grade 3/4

Median time to onset
8 days

Median duration
6.5 days

RWE

CAR T-Cell Consortium4

0%

Grade 3/4

Median time to onset
4 days

Median duration
4 days

 

In the US CAR T-Cell Consortium, 63% of patients were infused in the outpatient setting.4

Sustained & clinically-meaningful improvements for responding patients across all domains at 3, 6, 12, & 18 months (patient-reported outcome measures, N=99)5

Kymriah causes responses that correspond with long-term improvement in patient quality of life5

Image to show that Kymriah causes responses that correspond with long-term improvement in physical, emotional, functional and social/family wellbeing.

*CRS in JULIET was graded using the Penn Scale. CRS in real-world registries was graded using the ASTCT scale.
Data taken from 32.6-month analysis.1,2
The median time to onset refers to first grade 3/4 serious neurological events only.2
§The median time to resolution is among all the episodes of serious neurological adverse reactions.2
As measured by FACT-G, a 27-item questionnaire designed to measure four domains of health-related quality of life (HRQOL) in cancer patients. Responding patients defined as those with CR or PR.5

ASTCT, American Society for Transplantation and Cellular Therapy; CAR-T, chimeric antigen receptors cell therapy; CIBMTR, Center for International Blood & Marrow Transplant Research; CRS, cytokine release syndrome; DLBCL, diffuse large B-cell lymphoma; RWE, real-world evidence.

References

  1. Kymriah Summary of Product Characteristics; Novartis Pharmaceuticals UK Ltd.
  2. Data on file. CTL019C2201. 30 month follow-up report. Novartis Pharmaceuticals Corp; December 11, 2019.
  3. Pasquini MC, et al. Blood Adv. 2020; 4(21):5414–5424.
  4. Riedell P, et al. Transplantation & Cellular Therapy Annual Meeting; February 19-23, 2020; Orlando, FL. Presentation 52.
  5. Maziarz RT, et al. Blood Adv. 2020;4:629–637.
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UK | October 2021 | 144101
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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]