FDA eases restrictions on CAR-T cancer therapies

The FDA has removed its Risk Evaluation and Mitigation Strategies (REMS) for all approved CAR-T cell therapies, significantly loosening safety monitoring and post-treatment restrictions.

Why it matters: This move lowers logistical and cost barriers, potentially allowing broader patient access, especially in community healthcare settings where these therapies were previously out of reach.

Backstory: CAR-T therapies, approved since 2017, reengineer a patient’s immune cells to fight cancer. Due to early risks of severe immune and neurological side effects (CRS and ICANS), the FDA imposed strict oversight, including certified hospitals and prolonged post-treatment monitoring.

Consequence: Only ~20% of eligible patients currently access CAR-T due to logistical barriers, according to BMS.

Big picture: With physicians now experienced in managing side effects, and adverse event rates stable, the FDA's decision marks a turning point in mainstreaming CAR-T therapy. This could drive U.S. market expansion and improve outcomes for more blood cancer patients.

And the winner is: REMS removal applies to CAR-Ts from Novartis (Kymriah), BMS (Breyanzi, Abecma), Gilead (Yescarta, Tecartus) and J&J (Carvykti). Autolys Therapeutics’s Aucatzyl was already approved without a REMS program.