FDA Approves Rybrevant Faspro for Head and Neck Cancer

The U.S. Food and Drug Administration has granted accelerated approval to Rybrevant Faspro for adults with recurrent or metastatic head and neck squamous cell carcinoma, giving patients whose cancer kept growing after chemotherapy and immunotherapy a new option for the first time in a decade.

The approval, announced on November 5, 2026, covers patients whose disease progressed during or after platinum-based chemotherapy and treatment with a PD-1 or PD-L1 inhibitor, according to the FDA. It does not cover patients with HPV-associated oropharyngeal cancer.

What the trial showed

Approval rested on results from the phase 1b/2 OrigAMI-4 trial, in which 102 adults with previously treated recurrent or metastatic disease received the drug on its own. Tumours shrank or disappeared in 42% of patients, including complete responses in 15%, and 56% of those who responded were still responding after six months.

The drug is given as an injection under the skin rather than an infusion, and it works by blocking the EGFR and MET proteins, which can help cancer cells grow. Johnson & Johnson, which makes the drug, said in a statement that it is the only dual-targeted therapy approved for this use. The treatment was previously approved for a form of non-small cell lung cancer carrying an EGFR mutation.

Head and neck squamous cell carcinoma starts in the moist lining of the mouth, throat, or voice box, and it often returns or spreads after initial treatment. Once the disease has progressed after chemotherapy and immunotherapy, options have been limited, and survival prospects for patients in that position are poor. That gap is why oncologists have waited for a new drug in this setting.

The trial was open-label, meaning patients and doctors knew which treatment was being given, and it had no comparison group, so the response rate cannot be set directly against other options. The agency also noted that the evidence comes from a single group of patients, and that survival outcomes were not part of the approval decision. Those limits are standard for accelerated approvals, which are designed to get promising treatments to patients with few options while further evidence is gathered.

Amivantamab, the active ingredient, is a bispecific antibody, meaning it is designed to attach to two targets at once. Hyaluronidase, the second ingredient, helps the drug spread under the skin so it can be given by injection instead of a drip. The combination was developed by Johnson & Johnson's Janssen Biotech unit.

What happens next

Because the approval is accelerated, it rests on response rate and how long responses lasted rather than on longer survival data. Continued approval may depend on results from the confirmatory phase 3 OrigAMI-5 trial, which is testing the drug alongside carboplatin and the immunotherapy pembrolizumab, sold as Keytruda, as an initial treatment for recurrent or metastatic disease. The FDA had granted the drug breakthrough therapy designation in February and priority review in July.

The approval also matters for how head and neck cancer is treated in clinics. Subcutaneous dosing can shorten appointment times compared with intravenous infusions, and it may suit patients who live far from a cancer centre. Clinics will still need to watch for side effects, and the drug's full safety profile will become clearer as more people receive it outside a trial. Health technology is moving in the same direction elsewhere: Google has developed cuffless hypertension screening for smartwatches.

The decision lands in a busy period for drug approvals. Canada recently approved a Moderna flu vaccine in a world first, and an AI-designed bird flu vaccine outperformed stockpiled shots in trials.

For patients, the approval changes the conversation after standard treatment stops working. Until now, the options at that stage were limited to clinical trials or further chemotherapy, neither of which works for most people. A treatment that shrank tumours in a substantial share of trial patients gives oncologists something concrete to offer, even though the evidence so far rests on that trial group.

Results from the OrigAMI-4 trial were presented at the American Society of Clinical Oncology annual meeting earlier this year and published in the Journal of Clinical Oncology. Patients considering the treatment should discuss eligibility with their oncologist, including whether their cancer is HPV-associated, since that group is excluded from the approval. Read the FDA announcement, and Johnson & Johnson's statement.