Bispecific Antibodies: Expanding Access and Navigating Challenges in Multiple Myeloma Care
The landscape of multiple myeloma treatment is rapidly evolving, with bispecific antibodies emerging as a promising therapy. While initial adoption has been largely centralized in academic medical centers, a growing consensus suggests significant potential for broader administration at the community level. However, realizing this potential requires addressing key hurdles related to regulation, education, infrastructure, and patient support.
From CAR-T Complexity to Bispecific Accessibility
For years, chimeric antigen receptor (CAR) T-cell therapy represented a breakthrough for heavily pre-treated myeloma patients. However, the complex manufacturing process, high costs, and lengthy turnaround times created significant access barriers. Bispecific antibodies offer a potentially more accessible alternative, bridging a critical gap in treatment options. A recent retrospective analysis highlighted the urgent need for new therapies, revealing a median overall survival of just 11.6 months after patients become triple-class refractory.1
Step-Up Dosing: A Divide Between Academic Centers and Community Practices
Administering bispecific antibodies safely requires careful step-up dosing to mitigate the risk of cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). Interestingly, approaches to step-up dosing differ significantly between academic centers and community practices. Many community practices currently refer patients to specialized centers for step-up dosing before transitioning back to local oncologists for maintenance therapy. This highlights a critical infrastructure gap.
Navigating REMS Requirements and Regulatory Hurdles
The Risk Evaluation and Mitigation Strategies (REMS) requirements associated with bispecific antibodies present a substantial challenge for community adoption. Strict adherence to package insert guidelines, often mandating inpatient monitoring, can be restrictive. Pharmacists, in particular, face a steeper learning curve for REMS certification compared to physicians. Practices operating without state board oversight may find these requirements particularly daunting.
The process of obtaining initial authorizations for bispecific therapies, like teclistamab and linvoseltamab, can also be a significant barrier, adding administrative burden to already stretched resources.
The Game-Changing Impact of Prophylactic Tocilizumab
The availability and increasing use of prophylactic tocilizumab is dramatically changing the outpatient administration landscape. Studies show a significant reduction in CRS incidence with prophylactic tocilizumab use.5 The recent FDA expansion of approval for biosimilar versions of tocilizumab offers further hope for reducing costs and improving access. Payers are becoming more receptive to coverage, particularly with the inclusion of tocilizumab in NCCN guidelines.
Biosimilar adoption, however, isn’t without nuance. Coverage decisions may hinge on the specific formulation, with some plans prioritizing biosimilars over innovator products.
Infrastructure and Staffing: Building Confidence and Capacity
Successful outpatient bispecific administration requires dedicated infrastructure and adequately trained staff. Key considerations include:
- Staffing & Training: Ensure nurses and pharmacists are thoroughly trained in recognizing and managing CRS and ICANS.
- Location: Proximity to a hospital for rapid intervention is crucial, especially for patients with comorbidities.
- EMR Integration: Shared electronic medical records facilitate seamless communication and care coordination.
- After-Hours Coverage: Establish clear protocols for managing potential toxicities outside of regular business hours.
As physicians gain experience, community practices will likely follow suit, mirroring the evolution seen with other therapies like rituximab.
Empowering Patients and Prioritizing Supportive Care
Patient selection is paramount. Patients with significant comorbidities or lacking a dedicated caregiver are generally better suited for inpatient treatment. Empowering patients with education and tools for self-management is also critical. This includes providing emergency medications like dexamethasone and clear instructions on when to seek immediate medical attention.
Beyond acute toxicity management, comprehensive long-term supportive care is essential, including intravenous immunoglobulin (IVIG) and infectious prophylaxis. Early dose de-escalation, when appropriate, can significantly improve patients’ quality of life.
Frequently Asked Questions (FAQ)
- What is a bispecific antibody?
- A bispecific antibody is a type of immunotherapy that binds to two different targets simultaneously, bringing cancer cells and immune cells together to enhance the immune response.
- What is CRS and how is it managed?
- Cytokine Release Syndrome (CRS) is a common side effect of bispecific antibodies. It’s managed with medications like tocilizumab and, in severe cases, corticosteroids.
- Why is caregiver support important?
- Caregivers provide essential support for patients undergoing bispecific antibody therapy, particularly during the initial step-up dosing phase and for monitoring potential side effects.
- Are biosimilars of tocilizumab effective for preventing CRS?
- Yes, while biosimilars may have “skinny labels” lacking the specific CRS indication, they can be utilized through therapeutic interchange protocols.
As the field continues to evolve, ongoing research and collaboration between academic centers and community practices will be essential to optimize bispecific antibody therapy and expand access to this potentially life-changing treatment for patients with multiple myeloma.
References
- Caffrey M. Bispecifics in new combos, new uses, and earlier lines of treatment in myeloma. AJMC. December 15, 2025. Accessed December 22, 2025. https://www.ajmc.com/view/bispecifics-in-new-combos-new-uses-and-earlier-lines-of-treatment-in-myeloma
- Wang PF, Yee CW, Gorsh B, et al. Treatment patterns and overall survival of patients with double-class and triple-class refractory multiple myeloma: a US electronic health record database study. Leuk Lymphoma. 2023;64(2):398-406. doi:10.1080/10428194.2022.2140284
- Keesari PR, Samuels D, Vegivinti CTR, et al. Navigating the economic burden of multiple myeloma: insights into cost-effectiveness of CAR-T and bispecific antibody therapies. Curr Hematol Malig Rep. 2025;20(1):3. doi:10.1007/s11899-024-00748-5
- NCCN Clinical Practice Guidelines in Oncology—Multiple Myeloma. Version 4.26. Published November 26, 2025. Accessed December 23, 2025. https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf
- Caffrey M. Bispecific antibodies in multiple myeloma are moving from clinical trials to community practice. Am J Manag Care. 2025;31(spec 11):SP825-SP827.
- Serani S. FDA expands approval for tocilizumab biosimilar to treat CRS. Targeted Oncology. August 7, 2025. Accessed December 22, 2025. https://www.targetedonc.com/view/fda-expands-approval-for-tocilizumab-biosimilar-to-treat-crs
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