Regulatory approval of photoimmunotherapy: photodynamic therapy that induces immunogenic cell death

Abstract

In September 2020, the Japanese government approved cetuximab saratolacan (previously known as RM-1929, commercial name: Akalux) for the treatment of unresectable locally advanced or recurrent head and neck cancer. Cetuximab saratolacan is a chemical conjugate of the photosensitizer IR700 with cetuximab, which targets EGFR. The treatment consists in the intravenous injection of cetuximab saratolacan, which binds to head and neck cancer cells expressing high levels of EGFR, followed by illumination of the tumor with red light (690 nm) for photodynamic therapy. This approach causes immunogenic cell death in malignant tissues, thus triggering a potent anticancer immune response.