For Healthcare Professionals Outside the US

For Healthcare Professionals Outside the US

NOW APPROVED
Chimeric antigen receptor (CAR) T-cell therapy.

A first in CAR-T cell therapy: KYMRIAH now approved for R/R DLBCL and paediatric/young adult B-cell ALL1

KYMRIAH is indicated for the treatment of:

  • Paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse
  • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy
View the KYMRIAH SmPC
The achievement
of sustained efficacy:

KYMRIAH delivers lasting high response rates where other therapies have failed1

KYMRIAH USES THE
4-1BB DOMAIN:

KYMRIAH uses a CAR construct that contains the 4-1BB costimulatory domain to enhance early T-cell expansion and long-term persistence1

The right experience
and commitment:

Novartis has developed a rigorous process to reliably and accurately deliver KYMRIAH, an individualised treatment, on a global scale

FLEXIBILITY AND CONVENIENCE:

KYMRIAH gives physicians and patients the flexibility of cryopreservation and the potential for a convenient outpatient experience1

FINDING QUALIFIED TREATMENT CENTERS*

For more information, please contact
For healthcare providers in Europe only.
For qualified treatment centers only: Click below to order KYMRIAH using the Novartis CellChain Program

*Not all centers will treat for both KYMRIAH indications.

transforming the treatment of
CD19-expressing cancers

Only KYMRIAH uses a CAR construct that contains the 4-1BB costimulatory domain1

  • An autologous, adoptive immunocellular therapy, KYMRIAH reprograms a patient's own T-cells to express a CAR that targets malignant (and other) B-cells
  • Specifically designed to enhance early T-cell expansion and long-term persistence of CAR-T cells

Lentiviral transduction delivers transgene encoding the CD19-specific CAR1

The KYMRIAH CAR-T cell therapy includes the CD19 antigen binding domain, a 4-1BB costimulatory domain, and a CD3ζ signalling domain. The 4-1BB costimulatory domain is designed to enhance early T-cell expansion and long-term persistence of CAR-T cells1-3

KYMRIAH CAR-T cells have the ability to bind to and eliminate CD19-expressing malignant and other B-cells1

Collaboration drives the creation of this transformative treatment

Partnership between the primary haematologist/oncologist and the KYMRIAH Treatment Center is crucial to the treatment process.

Select icon below to learn more about the KYMRIAH process

Patient Identification
1. Patient Identification

The treating physician identifies patients with R/R DLBCL or paediatric/young adult B-cell ALL that would be appropriate to receive KYMRIAH.

Cell Collection
2. Collection and Cryopreservation

Leukapheresis, when a patient’s own T-cells are collected from his or her blood, occurs over 3 to 6 hours. Within 24 hours, the leukapheresis material is cryopreserved. Cryopreservation allows leukapheresis to be scheduled at a time that is in the best interest of the patient.1

Manufacturing Continue on next line
3. Manufacturing

The patient’s cryopreserved cells are shipped via specialised courier to the manufacturing facility. Novartis has established the manufacturing capacity necessary to meet the needs of patients. The target end-to-end turnaround time is 25-28 days, from the time the cells are received to when they are returned back to the treatment center.

Lymphodepleting Chemotherapy
4. Lymphodepleting Chemotherapy

2 to 14 days before the KYMRIAH infusion, the patient will receive a short course of low-dose lymphodepleting chemotherapy. This prepares the body for the incoming KYMRIAH CAR-T cells and may help promote the cells' proliferation.1,4

Infusion
5. Infusion

The patient receives the autologous KYMRIAH CAR-T cells during a single infusion.
KYMRIAH can be administered in either an inpatient or outpatient setting at the treating physician’s discretion.1

Short-term Monitoring
6. Short-term Monitoring

The patient will need daily monitoring for 10 days following the infusion, after which they should stay close to their KYMRIAH Treatment Center for at least 4 weeks after KYMRIAH infusion for monitoring.1

Long-term Monitoring
7. Long-term Monitoring

Long-term monitoring is required, including monitoring for potential secondary malignancies. Patients should participate in an optional KYMRIAH registry.1

Manufacturing: Our success comes from our commitment to quality

Proven Process on a Global Scale

KYMRIAH has been studied in global clinical trials in 11 countries and 27 sites across Europe, United States, Canada, Australia, and Asia.5 Because of these trials, Novartis has demonstrated its ability to deliver KYMRIAH on a global scale.

Manufacturing Success Rate

Novartis had a high success rate in manufacturing KYMRIAH for patients in the pALL and DLBCL pivotal trials of our global clinical trial program.1

End-to-end Turnaround

The Novartis manufacturing process was designed to return the highest quality product to patients in a timely manner with a target end-to-end turnaround time of 25-28 calendar days.

Cryopreservation

Manufacturing KYMRIAH utilizes cryopreservation of immune cells, allowing greater flexibility for patients.1 Cryopreservation also extends storage for up to 30 months and ensures reliable shipping of leukapheresis material.

References:
1. Kymriah Summary of Product Characteristics. Novartis Pharmaceuticals Corp; 2018. 2. Milone MC, Fish JD, Carpenito C, et al. Chimeric receptors containing CD137 signal transduction domains mediate enhanced survival of T cells and increased antileukemic efficacy in vivo. Mol Ther. 2009;17(8):1453-1464. 3. Kawalekar OU, O'Connor RS, Fraietta JA, et al. Distinct signaling of coreceptors regulates specific metabolism of pathways and impacts memory development in CAR T cells. Immunity. 2016;44(2):380-390. 4. Klebanoff CA, Khong HT, Antony PA, Palmer DC, Restifo NP. Sinks, suppressors and antigen presenters: how lymphodepletion enhances T cell-mediated tumor immunotherapy. Trends Immunol. 2005;26(2):111-117. 5. Schuster SJ, Bishop MR, Tam CS, et al. Primary analysis of Juliet: a global, pivotal, phase 2 trial of CTL019 in adult patients with relapsed or refractory diffuse large b-cell lymphoma. 59th American Society of Hematology Annual Meeting and Exposition; December 9-12, 2017; Atlanta, GA. Abstract #577.