Pharmacy Practice in Focus: Oncology
Cone Health Cancer Center pharmacists lead bispecific T-cell engager rollout, boosting local access to care.
The introduction of advanced bispecific antibodies offers a novel mechanism for cancer care, creating new clinical pathways and opening the door to research into other tumor types.1 Despite the promise of these agents, uptake in community cancer centers lags that of their academic and tertiary counterparts.2 Unique coordination and management of adverse effects (AEs), the need to collaborate closely with acute care facilities, and access challenges prevent many centers from using bispecific antibodies.
With the increasing prevalence of these agents, it will be critical for community cancer centers to build programs focused on bispecific T-cell engagers (BiTEs) to improve access and provide optimal cancer care. This article explores the real-world implementation of BiTE therapies in a community oncology setting, highlights the importance of program development, and discusses next steps.
As of March 2026, 9 BiTE therapies have been approved for a variety of disease states, including both hematologic malignancies and solid tumors.3-11 In June 2025, the most recent BiTE was approved in the relapsed/refractory multiple myeloma (MM) setting, making this the fourth of its kind for hematologic malignancies.12 BiTE therapy is an emerging field with new trials evaluating its use in earlier lines of therapy and across additional disease states.13,14
BiTE agents are associated with significant AEs. Specifically, cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS), which most frequently occur during the initial step-up dosing.15 Depending on the agent and the risk associated with each specific step-up dose, hospitalization or observation is required, ranging from a few hours up to 48 hours.3,4 Additionally, many community cancer centers do not have specified advanced acute care services or weekend acute care oncologists to promptly assess patients.
Although a referral can ensure appropriate therapy monitoring, one of the largest barriers is patients’ need to travel to these academic medical centers for weekly or biweekly administration. Upon completion of the step-up dosing, the risk for CRS or ICANS significantly decreases, and, as seen in agents approved for hematologic malignancies, there is an increased risk of serious infections.4-9,11,12,16 In North Carolina, as in many states, this can result in an entire day of travel for appointments and treatment, depending on the patient’s home address. Anecdotally, patients have declined referrals due to travel constraints, prompting the decision to create a new community cancer center program for BiTE therapy.
Cone Health is a private, not-for-profit health care network based in the Piedmont Triad region of North Carolina. The network includes 5 system hospitals and a robust ambulatory services network. It serves as the flagship oncology program for many rural communities in North Carolina and southern Virginia; thus, providing comprehensive services to patients is paramount to ensure equitable access to guideline-directed therapy. Cone Health Cancer Center is a community-based ambulatory oncology program across 6 sites in the Cone Health geographic service area. The cancer center program provides services to both urban and rural populations across central North Carolina.
Discussions about adding this program began in December 2024. In January 2025, work started on the core group meetings with an initial go-live date at the end of April 2025. It was determined that phase 1 of this program would rely on partnerships with academic centers for at least the step-up dosing, and that patients would return to Cone Health for their maintenance doses. This allowed physicians to become more comfortable with learning the complexities of these agents. Before, this referral to external sites would cover the entirety of treatment, often resulting in extended travel time for weekly to monthly infusion appointments.
The program was designed to be pharmacist-driven, given the increased level of interaction in academic medical centers, so patients could return when in a stable condition. Additionally, pharmacists can reduce the strain on physicians by handling complex treatment coordination and decreasing the burden on patients. Multiple phases of this project were mapped to slowly onboard and educate staff about the nuances of new BiTE agents.
Phase 1 was limited to MM BiTE agents, as this is one of the largest disease states Cone Health sees, and included 2 providers who primarily see patients with hematologic malignancies. These decisions were made because of the Risk Evaluation and Mitigation Strategies (REMS) requirements for both providers and pharmacies, the need to optimize processes during program growth, and the need for careful monitoring and management of these patients by both physicians and pharmacists.4-6,12
Organizing a new program requires significant time and determination to lay out an action plan (Figure 1) and plan potential go-live dates. The first step was to create a collaborative group of specialists from our cancer center to participate in the main discussions and brainstorming ideas (Figure 2). This core group helped develop education pamphlets, treatment plans, presentations, guidelines, workflows, and expand into additional phases.
Table 1 outlines the items completed and hours spent on each portion. One of the largest hurdles was the extensive education required to administer BiTE therapies. Education spanned from outpatient oncology pharmacists, physician assistants, infusion nurses, and oncologists to inpatient pharmacists, nurses, and physicians in the emergency department, on the floor, and on the infectious disease team. This education included not only the risk of CRS and ICANS but also serious infections, which can occur at any time while patients are on therapy. Education was the most important aspect of creating this program, as the facility had no previous training or interaction with patients receiving BiTE therapy agents.16,17
Acute care collaboration and education were also necessary to ensure tocilizumab (Actemra; Genentech, Inc) was on formulary and stocked. The decision was made that patients would not receive tocilizumab in the ambulatory setting. Although patients typically only return for step-up dosing, those in the area always had access to the emergency department.
This program is highly pharmacist driven due to the need for prompt coordination and the substantial level of pharmacy involvement. The clinic pharmacist is involved in nearly every aspect of patient care related to coordination, including managing patient return scheduling, determining appropriate treatment dates, editing treatment plans for correct start dates and doses, assessing supportive care needs, and collaborating with the oncologist. Upon a patient’s return, the pharmacist also verifies patient education and provides updated patient wallet cards.
Additionally, the decision was made to have the oncology infusion pharmacist coordinator oversee the REMS program for the pharmacy. This role includes maintaining the required weekly REMS documentation for dosing, coordinating medication acquisition, and providing coverage during periods when the clinic’s BiTE pharmacist is unavailable. Pharmacist involvement has been instrumental in supporting the program’s growth since the first patient returned in early May 2025, helping streamline the transition process for both physicians and patients.
While still in its early stages, the program has successfully transitioned 7 patients (6 with MM and 1 with small cell lung cancer), with 3 additional patients expected to return in early November. Among the patients who have returned thus far, 42.8% (3/7) experienced either CRS or ICANS during step-up dosing. No patients have experienced CRS or ICANS after returning to Cone Health for maintenance therapy, and to date, only 1 patient has required admission for infectious complications.
Additionally, diffuse large B-cell lymphoma and follicular lymphoma agents have been approved through the pharmacy and therapeutics committee, and completion of the treatment plan is pending to support additional patient transitions. As of October 2025, 8 of the 9 BiTE agents have been added to the formulary. Work is ongoing to expand inpatient services and incorporate satellite cancer centers. Through close collaboration across the care team and the implementation of a pharmacist-led approach, complications have been mitigated through strong communication and comprehensive education for the care team.
ABOUT THE AUTHORS
Kaitlyn Schomburg, PharmD, CPP, is a clinical oncology pharmacist at Cone Health Cancer Center in North Carolina.
Nick Gazda, PharmD, MS, BCPS, CSP, FNCAP, is the director of Pharmacy, Oncology and Infusion at Cone Health Cancer Center in North Carolina
As BiTE therapies continue to evolve and expand across cancer care, it will be increasingly important for community oncology programs to develop the expertise required to manage these patients. Our program deliberately partnered with other institutions to build the necessary clinical and operational infrastructure to support BiTE therapy. Planning is underway to create capacity for scheduled BiTE therapy initiations to further expand the program’s reach and the number of patients served.
Through strategic planning, interdisciplinary collaboration, and partnerships across cancer care programs, BiTE therapy can be successfully implemented to expand patient access. As clinical evidence supporting BiTE use continues to grow across multiple tumor types, community oncology programs will play a critical role in broadening access to these novel therapies.
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