Accelerator-based BNCT as a drug–device regimen: system engineering, clinical evidence, and regulatory considerations
- 1Center for Medical Device Evaluation of NMPA
Abstract
Boron neutron capture therapy (BNCT) is a binary, tumor-selective radiotherapy modality that combines preferential delivery of boron-10 to tumor tissue with neutron irradiation to generate high-linear energy transfer particles in situ . The field has undergone a defining transition from reactor-based neutron sources to accelerator-based BNCT (AB-BNCT), enabling hospital-based deployment, broader clinical translation, and renewed global interest in indications with substantial unmet needs, particularly recurrent head and neck cancers and gliomas. However, AB-BNCT is intrinsically a drug–device regimen, requiring coordinated evaluation of the boron agent, neutron irradiation system, and dedicated treatment planning software, supported by end-to-end quality management, commissioning and routine quality assurance, and postmarket surveillance. This review summarizes the system-engineering foundations and current global landscape of AB-BNCT. We outline the therapeutic principle and key subsystems, including accelerator neutron sources, beam shaping assembly, patient positioning and setup, beam/dose monitoring, treatment control, and Monte Carlo–based BNCT treatment planning. We synthesize clinical evidence from reactor-era feasibility studies, accelerator-era registration programs, and emerging real-world evidence, including the Japanese Phase II registration study reporting an objective response rate of 71.4% in patients with unresectable recurrent or locally advanced head and neck cancer and subsequent nationwide postmarketing evidence. We also compare regulatory classification and approval pathways across the European Union, United States, Japan, and China. Finally, we discuss regulatory considerations relevant to the evaluation of BNCT devices in China. Continued advances in boron agents, accelerator engineering, and standardization, together with accumulated regulatory experience, may support broader clinical implementation of AB-BNCT. Further accumulation of evidence integrating beam physics, dosimetry, and clinical outcomes may facilitate cross-jurisdictional understanding and the continued clinical development of AB-BNCT.
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BibTeX
@article{wang2026acceleratorbased,
title = {{Accelerator-based BNCT as a drug–device regimen: system engineering, clinical evidence, and regulatory considerations}},
author = {Zehua Wang and Yue Wang and Yan Jiang and Qing Zhang and Xiaofang Gu and Lu Liu},
journal = {Frontiers in Oncology},
year = {2026},
month = oct,
doi = {10.3389/fonc.2026.1972504},
url = {https://www.frontiersin.org/articles/10.3389/fonc.2026.1972504/full},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Accelerator-based BNCT as a drug–device regimen: system engineering, clinical evidence, and regulatory considerations
AU - Zehua Wang
AU - Yue Wang
AU - Yan Jiang
AU - Qing Zhang
AU - Xiaofang Gu
AU - Lu Liu
PY - 2026
DA - 2026/10/23
JO - Frontiers in Oncology
DO - 10.3389/fonc.2026.1972504
UR - https://www.frontiersin.org/articles/10.3389/fonc.2026.1972504/full
AB - Boron neutron capture therapy (BNCT) is a binary, tumor-selective radiotherapy modality that combines preferential delivery of boron-10 to tumor tissue with neutron irradiation to generate high-linear energy transfer particles in situ . The field has undergone a defining transition from reactor-based neutron sources to accelerator-based BNCT (AB-BNCT), enabling hospital-based deployment, broader clinical translation, and renewed global interest in indications with substantial unmet needs, particularly recurrent head and neck cancers and gliomas. However, AB-BNCT is intrinsically a drug–device regimen, requiring coordinated evaluation of the boron agent, neutron irradiation system, and dedicated treatment planning software, supported by end-to-end quality management, commissioning and routine quality assurance, and postmarket surveillance. This review summarizes the system-engineering foundations and current global landscape of AB-BNCT. We outline the therapeutic principle and key subsystems, including accelerator neutron sources, beam shaping assembly, patient positioning and setup, beam/dose monitoring, treatment control, and Monte Carlo–based BNCT treatment planning. We synthesize clinical evidence from reactor-era feasibility studies, accelerator-era registration programs, and emerging real-world evidence, including the Japanese Phase II registration study reporting an objective response rate of 71.4% in patients with unresectable recurrent or locally advanced head and neck cancer and subsequent nationwide postmarketing evidence. We also compare regulatory classification and approval pathways across the European Union, United States, Japan, and China. Finally, we discuss regulatory considerations relevant to the evaluation of BNCT devices in China. Continued advances in boron agents, accelerator engineering, and standardization, together with accumulated regulatory experience, may support broader clinical implementation of AB-BNCT. Further accumulation of evidence integrating beam physics, dosimetry, and clinical outcomes may facilitate cross-jurisdictional understanding and the continued clinical development of AB-BNCT.
SN - 2234-943X
ER -