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

The flexibility to conveniently deliver CAR-T to more patients1

Convenient administration

Icon of infusion drip next to text:  Simple, one-time intravenous infusion;

Simple, one-time intravenous infusion1

Inpatient or outpatient administration*1

In the US CAR T-Cell Consortium data, 63% of patients were infused in the outpatient setting2

 

Lower resource utilisation vs other CAR-T therapies

 icon of screwdriver and spanner next to text: Less pressure on healthcare resources;

Less pressure on healthcare resources:2–5

  • e.g. ICU usage rate, reduced duration of hospital stay, option to infuse in the outpatient setting
 

Flexibility of cryopreservation

icon of calendar next to text: The only approved CAR-T to allow for onsite cryopreservation, enabling;

The only approved CAR-T to allow for onsite cryopreservation, enabling:6,7

 

icon showing '30 months storage' next to text: Early apheresis;

Early apheresis6

Material can be collected & stored at a time that is best for the patient

 

Icon showing '10 day window' next to text:  Flexible scheduling.

Flexible scheduling7

Frozen final product allows for flexible treatment scheduling if delays occur in shipping process (patient availability, weather, border controls, etc.) 

 

*Patients should be instructed to remain within proximity (within 1 hour travel time as per NHS England guidance) of a qualified clinical facility for at least 4 weeks following infusion.

CAR-T, chimeric antigen receptors cell therapy; ICU, intensive care unit; NHS, National Health Service.

References

  1. Kymriah Summary of Product Characteristics; Novartis Pharmaceuticals UK Ltd.
  2. Riedell P, et al. Transplantation & Cellular Therapy Annual Meeting; February 19–23, 2020; Orlando, FL. Presentation 52.
  3. Denlinger N, et al. Transplantation & Cellular Therapy Annual Meeting; February 19–23, 2020; Orlando FL. Presentation 401.
  4. Kuhnl A, et al. EHA 2020. Presentation S243.
  5. Sesquers P, et al. EHA 2020. Presentation EP1211.
  6. Data on file. Novartis CTL019 leukapheresis reference manual: leukapheresis collection. Novartis Pharmaceuticals Corp; 2016.
  7. Data on file. PVR5135-7A Shipping Validation Report: CTL019 pALL. Novartis Pharmaceuticals Corp; 2016.
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UK | October 2021 | 144103
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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]