U.S. FDA Removes Required REMS Program for Approval of Abecma (ide-cel) and for Breyanzi (liso-cel)

June 30, 2025—According to a June 26th press release from Bristol Myers Squibb (BMS), "the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved."

These changes aim to improve access to treatment by easing logistical burdens on patients, especially those who live far from treatment centers.

Key updates include:

• Driving restrictions reduced from 8 weeks to 2 weeks after treatment
• Proximity to healthcare facilities requirement shortened from 4 weeks to 2 weeks
• REMS programs removed, as healthcare providers are now deemed capable of managing side effects like cytokine release syndrome (CRS) and neurologic toxicities (NTs) without them

These changes are supported by real-world data showing most serious side effects occur within the first two weeks after infusion. BMS plans to expand access by partnering with more community cancer centers, making it easier for patients to receive CAR T therapy closer to home.

Patient advocacy groups praised the updates as a step toward reducing barriers and improving quality of life for people with blood cancers. To learn more, read the full press release button below.