Coordinated Clinical Care For CAR T Lymphoma Patients a Multidisciplinary Approach - Episode 6
Panelists discuss how the dissolution of REMS requirements and availability of outpatient CAR T therapy have significantly improved access by reducing monitoring restrictions and caregiver requirements.
Lynch describes the dramatic evolution in CAR T safety from 2017 to present, reflecting on the initial fear surrounding early treatments compared with current confidence in outpatient administration. The treatment has become significantly safer through accumulated experience in toxicity prevention and management. Most patients treated with lisocabtagene maraleucel now receive outpatient treatment, allowing them to sleep in their own beds and avoid hospital-associated deconditioning.
Recent regulatory changes have substantially improved treatment accessibility. The dissolution of Risk Evaluation and Mitigation Strategy (REMS) requirements has eliminated previous restrictions, including mandatory 30-day proximity to treatment centers, 8-week driving prohibitions, and 30-day caregiver supervision. These changes recognize that acute toxicity typically occurs within 2 weeks, after which patients can safely resume normal activities, including driving.
Dr Friedman anticipates these changes will be game-changing for patient acceptance. Many community patients previously declined CAR T due to logistical challenges, including transportation difficulties, financial constraints for extended hotel stays, or lack of available caregivers. The relaxed restrictions directly address these barriers, potentially converting previous refusals into treatment acceptances. Lynch shares a real-time example of a patient who couldn't arrange 30-day caregiver support but became eligible for treatment just as the restrictions were lifted, literally saving his opportunity for potentially curative therapy.