The U.S. Food and Drug Administration has granted accelerated approval to a new treatment for adults with advanced head and neck cancer whose disease has returned or spread after chemotherapy and immunotherapy, the agency announced on November 5, 2026. The drug, Rybrevant Faspro, is the first new approval in this setting in a decade, according to the FDA, and it shrank tumors in 42 percent of the patients in the trial that supported the decision.
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| File photo: The U.S. Food and Drug Administration headquarters in Silver Spring, Maryland. The FDA granted accelerated approval to Rybrevant Faspro on November 5, 2026. |
For patients whose cancer has already been through the standard treatments, options have been painfully thin. Once head and neck cancer comes back or spreads after platinum-based chemotherapy and an immune checkpoint drug, doctors have had little left to offer. The new approval gives those patients a fresh option, delivered as an injection under the skin rather than a long intravenous infusion.
The approval covers adults with recurrent or metastatic head and neck squamous cell carcinoma, the most common form of the disease, whose cancer progressed during or after platinum-based chemotherapy and an anti-PD-(L)1 antibody, a type of immunotherapy. One group is excluded: patients with oropharyngeal cancer linked to HPV, as determined by a laboratory test known as p16 immunohistochemistry.
The Approval in Detail
Rybrevant Faspro is the brand name for amivantamab and hyaluronidase-lpuj, made by Janssen Biotech, a Johnson & Johnson company. It is given as a subcutaneous injection at a strength of 160 milligrams per 2,000 units per milliliter. Johnson & Johnson described it as the first and only dual-targeted therapy for advanced head and neck cancer, because it blocks two proteins, EGFR and MET, that can help cancer cells grow and spread.
The drug is not new. It was previously approved for certain patients with EGFR-mutated non-small cell lung cancer, and this is its first approval outside of lung cancer.
The FDA moved quickly on this application, granting breakthrough therapy designation in February 2026 and priority review in July 2026. Johnson & Johnson announced the approval on November 5, 2026, and the FDA published its notice the following morning.
Because the decision is an accelerated approval, it rests on evidence that tumors shrank and stayed smaller, rather than on proof that the drug extends life. Continued approval may depend on the results of a confirmatory trial now under way.
What the Trial Showed
The approval is based on Cohort 1 of the OrigAMI-4 study, a multicenter, open-label phase 1b/2 trial that tested Rybrevant Faspro on its own in 102 adults with recurrent or metastatic head and neck squamous cell carcinoma. Every patient in the group had already received platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor, and their cancer had still progressed. The results were published in the Journal of Clinical Oncology.
The headline number is the overall response rate: 42 percent of patients saw their tumors shrink or disappear, as judged by independent reviewers who did not know which treatment the patients had received. Fifteen percent of patients had a complete response, meaning no remaining signs of cancer on scans, and 28 percent had a partial response.
The responses also proved durable. Among the patients whose tumors responded, 56 percent kept their response for more than six months, and the median time to first response was 6.6 weeks. Most patients saw at least some shrinkage: 84 percent of evaluable patients experienced a reduction in the size of their target tumors.
The study also tracked how long patients lived without their cancer worsening and how long they lived overall. Median progression-free survival was 6.8 months, and median overall survival was 12.5 months. The trial had no comparison group, so the response rate cannot be directly compared with other treatments, and the study was not designed to prove a survival benefit.
A Decade Without a New Option
The significance of the approval lies in how long patients in this situation have waited. According to the FDA, this is the first approval in 10 years for patients with recurrent or metastatic head and neck squamous cell carcinoma previously treated with platinum-based chemotherapy. The agency noted that currently approved therapies in this setting produce response rates of roughly 20 percent or lower — about half the rate seen with Rybrevant Faspro.
Head and neck cancers are a major public health burden in the United States. The National Cancer Institute estimates that about 72,770 Americans will be diagnosed with cancer of the oral cavity, pharynx, or larynx in 2026, and about 17,110 will die from these diseases — about 4 percent of all cancers diagnosed in the country.
The main risk factors are smoking, alcohol use, and infection with HPV. Survival varies sharply by the site of the cancer and whether it is linked to HPV: the five-year relative survival rate is about 69.9 percent for cancers of the oral cavity or pharynx and about 62.5 percent for cancer of the larynx, according to the National Cancer Institute.
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| File photo: A cancer researcher at work in a laboratory. Rybrevant Faspro targets two proteins, EGFR and MET, that can help cancer cells grow. |
How the Drug Works
Rybrevant Faspro is a bispecific antibody, a type of engineered drug designed to latch onto two targets at once. It binds to EGFR, the epidermal growth factor receptor, and to MET, the mesenchymal-epithelial transition factor — proteins on the surface of cancer cells that signal them to grow and divide. By blocking both at the same time, the drug aims to cut off two escape routes the tumor might use.
The "Faspro" version is formulated for injection under the skin, with the enzyme hyaluronidase helping the medicine spread through the tissue. That matters for patients and clinics: a subcutaneous injection is far quicker and simpler than the hours-long intravenous infusions that many cancer drugs require.
Safety and Side Effects
No new safety signals were identified in the head and neck trial, according to Johnson & Johnson, and most treatment-related side effects were mild to moderate. The most common on-target side effects were low albumin levels in the blood, reported in 50 percent of patients, rash in 37 percent, inflammation around the fingernails and toenails in 34 percent, and acne-like skin rash in 34 percent.
Administration-related reactions, which can include shortness of breath, flushing, fever, chills, chest discomfort, low blood pressure, and vomiting, occurred in 15 percent of patients, with no Grade 3 or higher events reported. The drug is not for patients with a known allergy to hyaluronidase or any of its other ingredients.
What This Means
For patients, the approval opens a door that has been closed for a decade. People whose head and neck cancer has returned or spread after chemotherapy and immunotherapy have faced a prognosis with few good options, and a treatment that shrinks tumors in more than four in ten patients — with complete disappearance in about one in seven — is a meaningful change. The fact that it is given as a quick injection under the skin, rather than an infusion, is a practical benefit for patients already worn down by treatment.
For the broader field, the approval is a test case for the FDA's accelerated approval pathway in head and neck cancer. The agency is betting on tumor shrinkage as a predictor of benefit, and the confirmatory trial will determine whether that bet pays off.
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| File photo: A doctor discusses treatment with a cancer patient in a hospital room. The new approval is for patients whose head and neck cancer returned or spread after chemotherapy and immunotherapy. |
What Happens Next
The key question now is the confirmatory trial. The phase 3 OrigAMI-5 study is testing Rybrevant Faspro combined with the chemotherapy drug carboplatin and the immunotherapy Keytruda (pembrolizumab) as a first treatment for recurrent or metastatic head and neck cancer. That trial, rather than the single-agent study behind this approval, will determine whether the drug keeps its place on the market.
Early results from the same research program are encouraging. In Cohort 5 of the OrigAMI-4 study, presented at the European Society for Medical Oncology Congress 2026, the combination of subcutaneous amivantamab with a PD-1 inhibitor and carboplatin produced a confirmed overall response rate of 77 percent in 22 previously untreated patients, including complete responses in 14 percent. Those numbers come from a small group and a different treatment setting, so they are a hint rather than proof — but they are the reason the phase 3 trial is being watched closely.
For the tens of thousands of Americans diagnosed with head and neck cancer each year, the approval is a modest but real step forward — the first new drug in this setting in ten years, and one that works by a different mechanism than anything that came before it.
Sources: U.S. Food and Drug Administration (November 5–6, 2026); Johnson & Johnson press release (November 5, 2026); CURE Today; Pharmaceutical Executive; Targeted Oncology; OncLive; Journal of Clinical Oncology (Burtness et al., 2026); National Cancer Institute / American Association for Cancer Research.
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