The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Johnson & Johnson’s (J&J) Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The approval covers patients whose cancer has progressed during or after treatment with platinum-based chemotherapy and immunotherapy. The treatment is not indicated for patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma.
Announced on November 5, 2026, the approval provides a new treatment option for patients with advanced head and neck cancer, where treatment choices have remained limited. According to the FDA, this is the first approval in 10 years of a new drug for patients with recurrent or metastatic HNSCC who have previously received platinum-based chemotherapy.
The decision was based on results from the OrigAMI-4 clinical trial, which included 102 patients with recurrent or metastatic HNSCC. The study evaluated the drug as a single treatment following previous chemotherapy and immunotherapy.
Results showed an overall response rate of 42%, meaning that tumors either shrank or disappeared in 42% of patients. Among those who responded to treatment, 56% maintained their response for at least six months.
The response rate was more than double that generally seen with currently approved treatments, which have response rates of around 20% or lower, according to the FDA.
Rybrevant Faspro is a subcutaneous formulation of amivantamab, a bispecific antibody that targets two proteins, EGFR and MET. Both proteins play important roles in cancer growth and progression. By targeting these pathways, the treatment is designed to help control tumor growth.
The FDA granted the drug Breakthrough Therapy designation for this indication before its approval. The application also received priority review.
However, the approval was granted under the FDA’s accelerated approval pathway. This means the drug received approval based on early clinical results, and additional studies are required to confirm its long-term clinical benefits.
The FDA has also highlighted several safety concerns associated with the treatment, including allergic reactions, administration-related reactions, lung inflammation, skin reactions, eye problems and potential harm to an unborn baby.
The approval marks an important development for Johnson & Johnson’s oncology portfolio, expanding the use of Rybrevant Faspro beyond its established role in lung cancer treatment.
For patients with recurrent or metastatic head and neck cancer who have already undergone chemotherapy and immunotherapy, the new approval offers another treatment option in an area with significant unmet medical need.