5 November 2026
FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma
Source: US Food and Drug Administration.
This is an important development because it represents the first new drug approval in ten years for people with recurrent or metastatic head and neck squamous cell carcinoma who have previously received platinum-based chemotherapy.
The treatment, Rybrevant Faspro (amivantamab and hyaluronidase), targets two proteins involved in cancer growth:
EGFR (epidermal growth factor receptor).
MET (mesenchymal-epithelial transition factor).
In a clinical trial involving 102 patients:
42% experienced a reduction or disappearance of their tumours.
15% of patients achieved a complete response.
Of those who responded, 56% maintained their response for at least six months.
The approval is for patients whose cancer has progressed following platinum-based chemotherapy and immunotherapy. It excludes HPV-associated oropharyngeal cancer.
Why this matters: A new treatment option is now available for a group of patients who have historically had very limited options. The approval is accelerated, so further studies are required to confirm longer-term clinical benefit.
