J&J wins FDA approval for Rybrevant Faspro after 42% tumour response rate

Johnson & Johnson has secured accelerated approval from the US Food and Drug Administration (FDA) for its cancer treatment Rybrevant Faspro, expanding the drug’s application to certain adults with recurrent or metastatic head and neck cancer.

The approval, announced on 5 November 2026, covers patients with head and neck squamous cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and treatment with an anti-PD-(L)1 antibody. The indication excludes patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma.

The FDA’s decision was supported by clinical trial results showing an overall response rate of 42% among 102 patients. This means that the tumours either decreased in size or disappeared following treatment. Among patients who responded, 56% maintained their response for at least six months.

Rybrevant Faspro demonstrates 42% response rate in clinical trial

The approval was based on Cohort 1 of the Phase 1b/2 OrigAMI-4 clinical trial, which evaluated Rybrevant Faspro as a single-agent treatment in 102 adults with previously treated recurrent or metastatic HNSCC.

According to the FDA, the overall response rate was 42%, compared with response rates of approximately 20% or less associated with currently approved therapies for this patient population.

The results also showed that 56% of patients who responded to treatment maintained their response for six months or longer.

Johnson & Johnson reported that the trial recorded complete responses in 15% of participants and partial responses in 28%, based on an independent review of the clinical data.

The findings formed the basis for the FDA’s accelerated approval decision, although further clinical evidence will be required to establish the treatment’s long-term clinical benefit.

Dual-targeted treatment expands beyond lung cancer

Rybrevant Faspro contains amivantamab and hyaluronidase-lpuj and is designed to target two proteins associated with cancer development: epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET).

These pathways are involved in tumour growth and progression. By targeting both, the treatment is designed to address biological mechanisms associated with the development of certain cancers.

The formulation is administered through a subcutaneous injection, which takes approximately five minutes, according to the Reuters report.

The latest approval extends Rybrevant Faspro’s application beyond non-small cell lung cancer, where it already has FDA-approved indications.

Johnson & Johnson said the head and neck cancer approval represents the first application of the dual-targeted therapy in this treatment setting.

FDA requires additional studies to confirm clinical benefit

The approval was granted through the FDA’s accelerated approval programme, which allows certain treatments for serious conditions to reach patients based on evidence from surrogate or intermediate clinical endpoints that are considered reasonably likely to predict clinical benefit.

However, the pathway requires additional studies to verify the treatment’s clinical benefit.

Johnson & Johnson will therefore need to complete further clinical research to support continued approval of the head and neck cancer indication.

The FDA has identified the ongoing Phase 3 OrigAMI-5 study as the confirmatory requirement for this approval. The study is intended to verify and describe the clinical benefit of the treatment in patients with recurrent or metastatic HNSCC.

J&J enters a competitive head and neck cancer treatment market

Rybrevant Faspro will compete in a treatment market that includes established immunotherapy drugs such as Merck’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab).

The FDA approval introduces another treatment option for patients whose disease has progressed following previous chemotherapy and immunotherapy.

For Johnson & Johnson, the decision provides an opportunity to extend the use of its EGFR- and MET-targeted treatment into another cancer indication. It also broadens the potential application of its oncology research beyond lung cancer.

The approval does not cover HPV-associated oropharyngeal squamous cell carcinoma, making patient eligibility an important consideration in the treatment’s commercial and clinical application.

What to watch next: The progress and results of the Phase 3 OrigAMI-5 study will be important in determining whether the accelerated approval can be converted into continued approval supported by confirmatory evidence.

For the pharmaceutical industry, the development also highlights the role of targeted therapies and accelerated regulatory pathways in bringing new oncology treatments to market.

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