Referring the patient to a hospital qualified in YESCARTA^®/TECARTUS^® treatment

Referring hospital: haematologist, oncologist, and administrative personnel  

YESCARTA^®/TECARTUS^® treatment can only be given in qualified hospitals that have completed a training programme. In Sweden, the qualified hospitals are; Karolinska University Hospital, Huddinge, Sahlgrenska University Hospital, Gothenburg, Skåne University Hospital, Lund, Akademiska University Hospital, Uppsala, Linköping University Hospital, Linköping, Norrlands Universitetssjukhus, Umeå. Unless the patient is already under the care of one of these five hospitals, referral will be required.

It is important that patients who are potential candidates for YESCARTA^®/TECARTUS^® treatment are referred promptly because the process for approving the patient’s access to YESCARTA^®/TECARTUS^® and manufacturing the treatment takes a number of weeks.¹

Seeking approval for the prescription of YESCARTA^®/TECARTUS^®

The referring physician or CAR T treating physician at the qualified hospital will need to seek approval of the use of YESCARTA^®/TECARTUS^® for the patient. Contact The Swedish RCC-CAR T group that has regular Virtual/digital MDK meetings where all patients eligible for CAR T must be discussed. Email address for registration of a patient: CARMDK@akademiska.se. 

The detailed process for referring a patient according to the national Aggressive Lymphoma Guidelines and the RCC-CAR T group² is found here. 

Consideration of optimal therapy for the patient prior to YESCARTA^®/TECARTUS^®

Referring physician and treating physician 

To ensure that the patient’s symptoms and disease are managed during the referral and approval period, the referring physician should carefully consider the treatment prior to treatment with YESCARTA^®/TECARTUS^®, including bridging therapy. Optimal bridging therapy is an important part of preparing for CAR-T^3,4. Bridging therapy refers to treatments given between apheresis and the initiation of lymphodepleting chemotherapy. The goal of bridging therapy is to prevent rapid disease progression during this interval period and prior to CAR T cell infusion. Mainly three types of bridging therapies have been used in trials involving CAR T cells: immunotherapy, chemotherapy and/or targeted therapy, and radiotherapy.^5* Bridging therapy selection is highly variable between patients and is typically specific to both patient and healthcare provider. 

Consideration of bridging therapy is important because disease progression and related adverse events could prevent the patient from receiving YESCARTA^®/TECARTUS^®.³ Conversely, certain treatments could jeopardize the collection of T cells required for the manufacture of YESCARTA^®/TECARTUS^®. For example, lymphotoxic combinations including bendamustine, fludarabine, cladribine, and pentostatin should be avoided, and all therapies including immunosuppressive therapies and corticosteroids require a washout period.^1,6 It is extremely important that the referring physician discusses bridging treatment options and timing with the treating hospital before these are prescribed.¹ 

*Bridging therapy was not allowed in ZUMA-1 trial. 

References

1. Jain T, et al. Use of chimeric antigen receptor T cell therapy in clinical practice for relapsed/refractory aggressive B cell non-Hodgkin lymphoma: an expert panel opinion from the American Society for Transplantation and Cellular Therapy. Biol Blood Marrow Transplant 2019;25:2305-21.
2. Regionala cancercentrum i samverkan. Aggressiva B-cellslymfom. Nationellt vårdprogram, 2023-01-25 Version: 6.0 https://kunskapsbanken.cancercentrum.se/diagnoser/aggressiva-b-cellslymfom/vardprogram/. Accessed February 2023
3. Nastoupil, L. J. et al. Axicabtagene ciloleucel (Axi-cel) CD19 chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory large B-cell lymphoma: real world experience. Blood 132, 91 (2018).
4. Jain, M. D. et al. Characteristics and outcomes of patients receiving bridging therapy while awaiting manufacture of standard of care axicabtagene ciloleucel CD19 chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory large B-cell lymphoma: results from the US Lymphoma CAR-T. Consortium. Blood 134 (Suppl. 1), 245 (2019).
5. Amini, L. et al. Preparing for CAR T cell therapy: patient selection, bridging therapies and lymphodepletion. Nature Reviews Clinical Oncology volume 19, pages 342–355 (2022).
6. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines®): B-cell lymphomas, Version 2.2021. 16 February 2021.