- The FDA has approved label updates for Bristol Myers Squibb's CAR T cell therapies, Breyanzi® and Abecma®.
- The updates reduce patient monitoring requirements and remove REMS programs, potentially increasing access to treatments.
- Approximately 20% of eligible patients currently receive cell therapy due to logistical and geographic barriers.
The U.S. Food and Drug Administration (FDA) has approved significant updates to the labels of Bristol Myers Squibb's (BMY, Financial) CAR T cell therapies, Breyanzi® and Abecma®. These updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that were previously mandatory. This change reflects the growing evidence of the therapies' safety and efficacy, and aims to facilitate better access for patients.
The label updates for Breyanzi® (lisocabtagene maraleucel; liso-cel) and Abecma® (idecabtagene vicleucel; ide-cel) include reducing driving restrictions from 8 weeks to 2 weeks post-treatment, and decreasing the requirement for patients to stay near a healthcare facility from 4 weeks to 2 weeks. This alleviates some logistical burdens on patients and healthcare systems that were previously seen as barriers to treatment.
Only about 2 in 10 eligible patients currently undergo cell therapy due to barriers that include geographic and logistical challenges. With the FDA's decision, there's potential for increased access to these life-saving treatments. The FDA's approval to remove the REMS requirement indicates they trust the established medical guidelines and the healthcare community's ability to manage potential side effects without the need for additional oversight.
With this announcement, Bristol Myers Squibb aims to broaden its network of certified treatment centers, focusing on expanding geographical coverage and reducing travel burdens for patients. This aligns with the company's commitment to democratizing access to transformative cell therapies, ensuring more patients can benefit from these advances in cancer treatment.
Lynelle B. Hoch, president of the Cell Therapy Organization at Bristol Myers Squibb, emphasized the company's dedication to challenging existing barriers and practices to enhance access to CAR T cell therapies, which provide potentially life-saving options for patients with blood cancers.
As Bristol Myers Squibb continues to innovate within the field, the organization remains focused on shaping the future of cell therapy for a broader patient base across various markets worldwide. For more information about Bristol Myers Squibb's cell therapy programs, visit their dedicated site, CellTherapy360.com.
