Treatment Process for FL | KYMRIAH® (tisagenlecleucel)

Treatment Process

About CAR-T Cell Therapy

CAR-T cell therapy is a targeted, personalized therapy that contains patients’ autologous T cells reengineered to fight cancer. KYMRIAH^® (tisagenlecleucel) is a CAR-T cell therapy genetically modified to identify and eliminate CD19-expressing malignant and normal cells. Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T-cell expansion, activation, target cell elimination, and persistence of the KYMRIAH cells.¹

Patient Identification

Patient health and referral timing are important considerations

KYMRIAH may be appropriate for adults with r/r FL who have received two or more lines of systemic therapy and¹:

Have not gone into remission (refractory after second line of therapy)
Have relapsed (after second line of chemotherapy or following ASCT)

Timely referral is critical. Prior treatments may impact the overall quality of the patient’s T cells, which are used to manufacture KYMRIAH^2,3

Treatment Process

Diagram showing the steps in the KYMRIAH® (tisagenlecleucel) treatment

	Cell Collection and Cryopreservation The patient’s T cells are collected from the blood (leukapheresis). The material is cryopreserved, allowing leukapheresis to be scheduled at a time that is in the best interest of the patient.^1,a
	Manufacturing The patient’s cryopreserved cells are shipped to a Novartis FDA-registered and -approved manufacturing facility, where they are genetically reprogrammed into KYMRIAH CAR-T cells.¹
	Infusion The patient may receive lymphodepleting chemotherapy to prepare the body for KYMRIAH.¹ KYMRIAH is administered in either an inpatient or outpatient hospital setting at the treating physician’s discretion.³
	Monitoring The patient should stay within proximity of their KYMRIAH Treatment Center for at least 4 weeks after KYMRIAH infusion.¹ Patients should be encouraged to participate in a 15-year long-term follow-up registry.

^aLeukapheresis material from a previous collection may be used if it was collected within 30 months at a Novartis-approved apheresis collection facility.⁴

The KYMRIAH CAR-T Cell Therapy Manufacturing Process

The KYMRIAH manufacturing process utilizes cryopreservation, which allows for:

	Flexibility for patient scheduling⁴ You can schedule collections as soon as a patient is identified
	Optimal timing for leukapheresis⁴ Leukapheresis material collected at a Novartis-approved apheresis collection facility can be cryopreserved for up to 30 months before manufacturing begins, if you decide that is the best treatment course for your patient.^b KYMRIAH is the only commercially available CAR-T cell therapy that allows for early leukapheresis and extended storage of cryopreserved leukapheresis material
	Shipping⁵ The charged Dewar is validated to maintain cryogenic temperatures for 10 days, keeping the cryopreserved leukapheresis material frozen, and providing a safeguard against weather- and/or logistic-related delays
	Storage of excess cells⁴ It may be possible for excess cells to be retained at your facility for potential future use, if a collection yields greater than 4 x 10⁹ CD3⁺ cells and subject to certain storage requirements

^bKYMRIAH is individually manufactured for each patient; it is important to keep in mind that not all patients’ cells can be successfully manufactured into KYMRIAH CAR-T cells.⁴

For information about the mechanism of action, continue to the next page

Treatment Process

Important Safety Information for KYMRIAH^® (tisagenlecleucel)

Indication