Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates for its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) and Abecma (idecabtagene vicleucel; ide-cel) to treat multiple myeloma.
These updates reduce patient monitoring requirements and eliminate the Risk Evaluation and Mitigation Strategy (REMS) programme initially required upon each product’s approval.
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The changes aim to address logistical and geographic barriers that hinder access to cell therapy, which currently reaches only two in ten eligible patients, according to the company.
Bristol Myers Squibb stated that it is committed to expanding access to these therapies while maintaining patient safety, and supports the class-wide label updates.
Across both levels, the regulatory body has approved the reduction or elimination of certain patient monitoring requirements for both Breyanzi and Abecma.
Previously burdensome for healthcare systems and patients, particularly those far from certified centres, these changes include a reduction in driving restrictions from eight weeks to two weeks and also on the requirement to stay near healthcare facilities from four weeks to two weeks post-treatment.
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By GlobalDataBristol Myers Squibb Cell Therapy Organization president Lynelle B. Hoch said: “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.
“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 democratising access to cell therapy.”
The regulatory agency has also given approval to the removal of the REMS requirement from the product labels.
REMS programmes are typically implemented to address known or potential risks associated with new drugs or therapies.
However, the FDA has concluded that the established management guidelines and the extensive experience of the medical hematology and oncology community are adequate for diagnosing and managing the risks of side effects, including cytokine release syndrome (CRS) and neurologic toxicities (NTs), without the need for a REMS for the class of CD19- and BCMA-directed autologous CAR T cell therapies.
This change is expected to facilitate the further integration of cell therapy into community healthcare settings, stated the company.
These updates indicate the growing body of clinical and real-world evidence demonstrating the favourable efficacy and safety profile of CAR T cell therapy, added the company.
More than 30,000 patients have been treated with CAR T cell therapies, with studies including an analysis of BMS presented recently showing that most serious adverse events occur within the first two weeks of infusion.
Following the FDA’s decision, BMS will collaborate with over 150 treatment centres approved to administer Breyanzi and Abecma to remove the REMS programmes.
Concurrently, the company is focused on expanding the geographic reach of its cell therapies, aiming to include more community cancer centres nationwide.
A CD19-directed genetically modified autologous T cell immunotherapy, Breyanzi is intended for the treatment of adult patients with large B-cell lymphoma (LBCL).
A genetically modified autologous T cell immunotherapy, Abecma targets B-cell maturation antigen (BCMA). It is approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have undergone two or more earlier lines of therapy.
Last month, European Commission approved the new subcutaneous (SC) formulation of Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) with a dosage strength of 600 mg/vial, expanding treatment options for various adult solid tumours.
