Johnson & Johnson Receives Breakthrough Therapy Designation for RYBREVANT FASPRO™ for the Treatment of Advanced Head and Neck Cancer
Johnson & Johnson has introduced RYBREVANT FASPRO™ for the treatment of patients with advanced head and neck squamous cell carcinoma (HNSCC).
RYBREVANT FASPRO™ is a subcutaneous therapy designed to target both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) pathways, which are commonly overexpressed in this type of cancer. By targeting these pathways, the therapy aims to control tumour growth and support immune system activity in patients with limited treatment options.
The designation is supported by clinical data from the Phase 1b/2 OrigAMI-4 study, which evaluated the therapy in patients who had already received multiple prior treatments. The study showed encouraging results, including rapid and durable responses. Based on these findings, the therapy is being further studied in the ongoing Phase 3 OrigAMI-5 trial. This study is assessing RYBREVANT FASPRO™ in combination with pembrolizumab and chemotherapy compared with standard treatment options in first-line settings.
The treatment is currently approved in multiple regions for lung cancer and continues to be studied in other solid tumours, including head and neck cancer, as part of its broader clinical development programme.
Head and neck squamous cell carcinoma is the most common form of head and neck cancer and accounts for the majority of cases worldwide. It develops in the lining of areas such as the mouth, throat, and voice box. Risk factors include tobacco use, alcohol consumption, and infection with human papillomavirus. However, HPV-negative cases are more difficult to treat and are often linked to poorer outcomes. Many patients eventually progress to advanced stages despite available therapies.
RYBREVANT FASPRO™ is based on the intravenous formulation RYBREVANT®, which has already shown clinical benefit in patients with EGFR-mutated non-small cell lung cancer. The therapy is a bispecific antibody that targets both EGFR and MET pathways and is designed to improve treatment response and delay disease progression.
