Proposal of recommended experimental protocols for in vitro and in vivo evaluation methods of boron agents for neutron capture therapy

Recently, boron neutron capture therapy (BNCT) has been attracting attention as a minimally invasive cancer treatment. In 2020, the accelerator-based BNCT with L-BPA (Borofalan) as its D-sorbitol complex (Steboronine & REG;) for head and neck cancers was approved by Pharmaceutical and Medical Devices Agency for the first time in the world. As accelerator-based neutron generation techniques are being developed in various countries, the development of novel tumor-selective boron agents is becoming increasingly important and desired. The Japanese Society of Neutron Capture Therapy believes it is necessary to propose standard evaluation protocols at each stage in the development of boron agents for BNCT. This review summarizes recommended experimental protocols for in vitro and in vivo evaluation methods of boron agents for BNCT based on our experience with L-BPA approval.

Automated summary

Recently, boron neutron capture therapy (BNCT) has gained attention as a minimally invasive cancer treatment. The approval of accelerator-based BNCT with L-BPA (Borofalan) for head and neck cancers in 2020 marked a significant milestone. The development of novel tumor-selective boron agents is crucial, especially with the advancements in accelerator-based neutron generation techniques. This review summarizes recommended experimental protocols for evaluating boron agents for BNCT based on the experience with L-BPA approval.