The US Food and Drug Administration has approved a new treatment for adults with advanced head and neck cancer, the first drug approval in a decade for patients whose disease has returned after standard treatment.
Rybrevant Faspro, made by Johnson & Johnson, is a subcutaneous injection combining amivantamab with hyaluronidase. It is approved as a single treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma whose cancer has progressed after platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 immunotherapy.
The approval, announced on 5 November, rests on results from the phase 1b/2 OrigAMI-4 trial, in which 102 patients received the drug. Tumours shrank or disappeared in 42% of patients, including complete responses in 15%, and more than half of those who responded were still responding after six months.
It is also the first dual-targeted therapy approved in this setting, designed to block two proteins that help tumours grow: epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (MET). The drug is given as an injection under the skin rather than an intravenous infusion.
The approval does not cover patients whose cancer is linked to human papillomavirus (HPV)-associated oropharyngeal cancer. The FDA had previously granted the drug breakthrough therapy designation in February 2026 and priority review in July.
The approval is accelerated, meaning it was granted on the basis of tumour response rates rather than proof of longer survival. Continued approval may depend on a confirmatory phase 3 trial, OrigAMI-5, which is testing the drug in combination with carboplatin and pembrolizumab as a first treatment for advanced head and neck cancer.
Head and neck squamous cell carcinoma is among the most common cancers worldwide, and patients whose disease returns after chemotherapy and immunotherapy have had very few options. The FDA noted that currently approved therapies in this setting shrink tumours in around 20% of patients or fewer.
Sources: US Food and Drug Administration, “FDA grants accelerated approval to a new treatment for head and neck squamous cell carcinoma” (https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-treatment-head-and-neck-squamous-cell-carcinoma); Johnson & Johnson, “Johnson & Johnson announces U.S. FDA Approval of RYBREVANT FASPRO as First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer” (https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-u-s-fda-approval-of-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-as-first-and-only-dual-targeted-therapy-for-advanced-head-and-neck-cancer).
