Adverse events of cetuximab sarotalocan in photoimmunotherapy: insights from the Japanese adverse drug event report database.

PURPOSE: Cetuximab sarotalocan is an innovative photoimmunotherapy agent for cancer treatment, with an unclear safety profile. We analysed the clinical adverse event profile of cetuximab sarotalocan in photoimmunotherapy. METHODS: In this retrospective study, we analysed real-world clinical data of patients with head and neck cancer from the Japanese Adverse Drug Event Report database. Patient demographics, as well as the nature of adverse events and their outcomes and co-occurrences, were analysed. RESULTS: Cetuximab sarotalocan adverse event reports (n = 227) predominantly included older male patients. The most frequent adverse event was laryngeal oedema, followed by upper respiratory and oral complications. Recovery rates were high for laryngeal oedema and tongue-related adverse events but poor for fistula-related complications. Co-occurrence was found between different adverse events, particularly laryngeal oedema and dysphagia. CONCLUSION: The described safety profile of cetuximab sarotalocan in photoimmunotherapy offers insights for its proper use as well as baseline data for the development and improvement of cancer photoimmunotherapy.