FDA Approves CAR T Therapy Label Updates Across Various Blood Cancers

Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and multiple myeloma, respectively.

Labeling updates have been approved by the U.S. Food and Drug Administration for treatment with two CAR T-cell therapies: Breyanzi (lisocabtagene maraleucel; liso-cel) in large B cell lymphoma (LBCL) and other lymphomas and Abecma (idecabtagene vicleucel; ide-cel) in multiple myeloma, according to a news release from Bristol Myers Squibb.

Currently, approximately 2 in 10 eligible patients receive cell therapy, but this announcement is expected to help eliminate unnecessary barriers for both patients and providers. These updates ease specific patient monitoring requirements and eliminate the Risk Evaluation and Mitigation Strategy (REMS) programs that were implemented at the time of each therapy’s initial approval. Moreover, the updated labeling reflects increasing real-world evidence and regulatory confidence in the safety of CD19- and BCMA-directed autologous CAR T-cell therapies, supporting ongoing efforts to improve equitable access.

“CAR-T cell therapy is a transformational, potentially life-saving option for patients living with blood cancers, and we are working to challenge current practices, assumptions and barriers that limit access,” Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb, said in the news release. “Today's FDA-approved label updates reinforce BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy.”

Diving Into the Labeling Updates

Despite the benefit of cell therapy, there are still many challenges that affect both patients, the news release states, leading to benefit with this class-wide label updates. The FDA-approved label updates to Breyanzi and Abecma both reduce and remove specific patient monitoring requirements, for example. Other updates include a reduction in post-treatment driving restrictions from eight weeks to two weeks, and a shortened requirement to remain near a treatment facility from four weeks to two weeks.

Additionally, the FDA has removal of REMS from both labels is a big update. Although REMS programs are typically used to manage potential risks associated with new therapies, the FDA now recognized that current guidelines and the hematology/oncology community’s experience are sufficient to identify and address side effects, such as cytokine release syndrome and neurologic toxicities, without a formal REMS program. This change is expected to help expand the availability of CAR T into more community-based settings, the news release emphasized.

“Living with blood cancer is challenging, but patients and their loved ones still need to maintain jobs, take care of families, and plan for the future,” Sally Werner, chief executive officer, Cancer Support Community, added. “Today’s announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy. We applaud any and all efforts to continue to break down barriers, reduce time burden on patients and caregivers, and increase uptake of this life-saving therapy.”

Overall, these updates reflect the growing clinical and real-world understanding of these treatments, supporting the efficacy and safety of CD19- and BCMA-directed autologous CAR T-cell therapies. More than 30,000 patients have received CAR T treatment to date, and recent findings indicate that most serious side effects occur within the first two weeks of infusion.

Looking to the future, the news release says that Bristol Myers Squibb will be working closely with over 150 treatment centers who currently administer Breyanzi and Abecma to remove the REMS programs. In tandem, the company is also focusing on expanding the geographic footprint of CAR T therapy. This will, in turn, reflect a renewed effort to help community cancer centers administer Breyanzi and Abecma closer to patients, aiding in the reduction of travel time and duration of stay away from home, as well as family and work.

Reference:

“U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels,” Bristol Myers Squibb.

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