Autoimmune CAR-T: Navigating the FDA’s new regulatory playbook

For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases. But the application of these engineered cell therapies is expanding to reset the immune system for patients living with lupus, stiff person syndrome and other autoimmune conditions. And with new frontiers come new rules.

In this week’s episode of "The Top Line," Fierce Pharma’s Angus Liu chats with Harpreet Singh, M.D., chief medical officer at Precision for Medicine and a former director of the FDA's Division of Oncology, about a recent article by FDA officials led by CBER Director Vinay Prasad, M.D., laying out the agency’s perspective on its regulation of autoimmune CAR-T therapies. Singh discusses how the agency’s "case-by-case" approach, as indicated in the article, could be similar to—and different from—CAR-T for oncology indications. She also talks about how drug developers should follow existing development experience, as well as prepare for specific requirements for long-term patient follow-up and potential new clinical endpoints from the agency.

To learn more about the topics in this episode:

FDA signals tailored approach to ‘carefully shepherd’ CAR-T therapy for autoimmune diseases

Kyverna gains clear view to first CAR-T approval for autoimmune disease after 'truly remarkable' SPS readout

Cabaletta CAR-T wipes out B cells without preconditioning in small autoimmune trial

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