FDA Removes REMS Requirements for CAR-T Therapies, Paving the Way for Broader Patient Access

The U.S. Food and Drug Administration (FDA) has removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for currently approved BCMA- and CD19-directed CAR-T therapies, the agency announced on June 26, 2025 (Source: Fierce Pharma).

Existing commercial CAR-T products—including Bristol Myers Squibb's Abecma and Breyanzi, Gilead Sciences' Yescarta and Tecartus, Johnson & Johnson and Legend Biotech's Carvykti, and Novartis' Kymriah—stand to benefit from this update. Autolus' CD19 CAR-T therapy, Aucatzyl, was approved in November for B-cell precursor acute lymphoblastic leukemia without a REMS requirement.

Previously, REMS requirements mandated that hospitals and clinics be specially certified to administer CAR-T therapies due to risks such as cytokine release syndrome and neurological toxicities. According to the FDA, these safety concerns are now considered manageable, thanks to established clinical guidelines and extensive experience within the hematology/oncology community.

Analysts at Leerink Partners have noted that the previous REMS requirements created significant barriers, discouraging referrals from community doctors and affecting patients’ willingness to receive CAR-T therapies. With the new guidance, reduced monitoring and driving restrictions are expected to increase patient uptake, particularly for CD19-directed therapies, whose market penetration had remained around 20%.

Industry Insight:

This regulatory change highlights the growing importance of scalable, GMP-compliant CDMO services. As CAR-T therapies become more accessible, manufacturing partners capable of supporting efficient, end-to-end cell and gene therapy production are crucial to meet increasing demand while maintaining quality and safety.

About us:

Hillgene is a global CDMO specializing in cell and gene therapies. With state-of-the-art GMP facilities and comprehensive process development capabilities, we partner with biotech innovators to accelerate the delivery of transformative therapies to patients worldwide.

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