The US FDA granted accelerated approval on 5 November 2026 to Johnson & Johnson's Rybrevant Faspro, injected amivantamab with hyaluronidase, for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum chemotherapy and an anti-PD-(L)1 antibody. In 102 patients, 42% responded. It has no EU authorisation for this use.
The approval rests on response data from an open-label study, not on proof that patients live longer. The FDA says the benefit still has to be confirmed. For Irish readers there is one sourced link: the EU product information for Rybrevant names J&J's Ringaskiddy site in Cork as a manufacturer of the active substance.
- Decision: FDA accelerated approval on 5 November 2026 for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), used as a single agent, granted to Janssen Biotech, Inc.
- Patients: adults whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. It is not indicated for HPV-associated oropharyngeal squamous cell carcinoma.
- Evidence: OrigAMI-4, a Phase 1b/2 open-label study. Overall response rate was 42% in 102 patients, and 56% of responders had a response lasting six months or longer.
- Still to prove: J&J names the Phase 3 OrigAMI-5 study as the confirmatory trial. Its primary completion is estimated for June 2029.
- EU and Ireland: the EU indications for Rybrevant cover lung cancer only. We found no public record of an EU application for head and neck cancer.
What exactly did the FDA approve?
Rybrevant Faspro is a subcutaneous injection that combines the antibody amivantamab with hyaluronidase. It is given on its own for this use, at a dose based on body weight. Patients in the trial received it every three weeks until the disease progressed or side effects became unacceptable, and J&J says eligible patients may have it every three or four weeks. Amivantamab targets two proteins, EGFR and MET.
The FDA called this "the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy". J&J's headline calls the product the "First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer". That second phrase is the company's description. J&J also says this is the first indication for Rybrevant Faspro beyond non-small cell lung cancer.
The FDA reviewed the application with priority review and breakthrough therapy designation. The review ran under Project Orbis, with Brazil's ANVISA, Health Canada, Israel's Ministry of Health and Singapore's Health Sciences Authority named as partners. The FDA notice does not name the European Medicines Agency or the HPRA as partners. Full US prescribing information was due to be posted on Drugs@FDA.
What did the OrigAMI-4 trial show?
OrigAMI-4 is a multicentre, open-label, multi-cohort study registered as non-randomised. The approval draws on Cohort 1, in which 102 previously treated patients received amivantamab alone. Patients with HPV-associated oropharyngeal cancer were excluded from this population. J&J's medical information page says 52% had one prior line of therapy and 48% had two.
The results were presented at the ASCO Annual Meeting on 31 May 2026 and published in the peer-reviewed Journal of Clinical Oncology. The lead sponsor is J&J's Janssen Research & Development, and the data below come from the FDA and from J&J.
| Measure | Result |
|---|---|
| Patients in primary efficacy population (FDA) | 102 |
| Overall response rate, blinded independent central review (FDA) | 42% (95% CI 32% to 52%) |
| Responders with response lasting six months or longer (FDA) | 56% |
| Complete response (J&J) | 15% |
| Median follow-up (J&J) | 11.8 months |
| Median progression-free survival, investigator assessed (J&J) | 6.8 months (95% CI 5.2 to 8.3) |
| Median overall survival (J&J) | 12.5 months (95% CI 10.2 to 16.8) |
J&J's partial response figure differs slightly between documents: 27% in its May release and medical information page, and 28% in its November release. The company did not explain the difference in the material we read.
The FDA says currently approved therapies have an overall response rate "of around 20% or less". This is not a head-to-head result. No randomised comparison was behind the 42% figure, so survival figures from this cohort cannot show that the drug extends life compared with other treatment.
What side effects were reported?
The FDA lists warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease or pneumonitis, skin reactions, eye toxicity and harm to an unborn baby.
J&J's release gives the most common adverse reactions in OrigAMI-4 as rash (79%), fatigue (39%), nail toxicity (35%), stomatitis (32%) and oedema (28%). Serious adverse reactions occurred in 39% of patients and fatal adverse reactions in 6%. J&J's medical information page says one of those deaths, from pneumonitis, was treatment related and that the other five were judged unrelated. It also reports grade 3 or higher adverse events in 60% of patients and treatment-related discontinuation in 8%.
What does accelerated approval mean?
The FDA says the programme allows earlier approval of drugs for serious conditions with an unmet medical need, based on surrogate or intermediate endpoints. Here those endpoints were overall response rate and duration of response. The agency adds: "Since it is not yet confirmed whether this will translate into a clinically meaningful benefit in long-term outcomes, the FDA has required confirmatory studies to verify and describe clinical benefit."
J&J names OrigAMI-5 as the confirmatory trial and says continued approval may depend on it. OrigAMI-5 (NCT07276399) is a randomised Phase 3 study with an estimated 600 patients. It tests a different setting from the new indication: first-line treatment, with amivantamab added to pembrolizumab and carboplatin, against pembrolizumab with 5-FU and carboplatin or cisplatin. Its primary measures are overall survival and objective response rate. It began on 3 December 2025 and is still recruiting.
What did the FDA and clinicians say?
Angelo De Claro, director of the FDA's Oncology Center of Excellence, said: "Today's approval represents a meaningful step forward for patients with head and neck squamous cell carcinoma, a disease where treatment options have historically been limited and outcomes remain poor."
Barbara Burtness, a medical oncologist at Yale Cancer Center, said in J&J's release: "The meaningful responses observed in this study are encouraging for patients who have long faced limited treatment options." The release notes that she has served as a consultant to J&J.
Is the drug available in the EU and Ireland?
Not for this use. Rybrevant has been authorised in the EU since 9 December 2021. The EMA's product information lists lung cancer indications only, for both the infusion and the subcutaneous formulation. The EMA's medicine page was last updated on 16 July 2026, and it does not mention head and neck cancer.
We found no sign of an EU application. Amivantamab and Rybrevant do not appear in the published CHMP agendas for September and October 2026, and J&J's release does not mention a European filing. That does not rule out an application we cannot see. Availability in Ireland for this use is not known. You can follow EU decisions on our EMA approvals tracker and US decisions on our FDA approvals tracker.
Any future Irish funding would also need a separate decision. The National Centre for Pharmacoeconomics (NCPE) has already assessed amivantamab in lung cancer. In March and May 2026 it recommended against reimbursement in two lung cancer uses unless cost effectiveness can be improved. The HSE makes the final decision, as in the process we described in our report on lecanemab.
| Item | Status |
|---|---|
| US FDA | Accelerated approval, 5 November 2026 |
| EU indication | None, lung cancer only |
| NCPE assessment for this use | None found |
| Irish sites listed for OrigAMI-4 on ClinicalTrials.gov | None |
| Irish sites listed for OrigAMI-5 on ClinicalTrials.gov | None (UK and several EU countries are listed) |
What is the Irish connection?
Annex II of the EU product information for Rybrevant lists two manufacturers of the biological active substance: Janssen Sciences Ireland UC at Barnahely, Ringaskiddy, Co. Cork, and Samsung Biologics in Incheon, South Korea. Batch release is listed at Janssen Biologics B.V. in Leiden, the Netherlands.
That is a fact about the EU product. The document does not show how much is made at each site, and we found nothing stating where the US product for this indication is made. J&J says the Ringaskiddy site "produces critical medicines for immunology and oncology patients". Its Irish page describes operations across nine sites in five counties. More on the molecule is on our amivantamab page.
Head and neck cancer is a real but smaller burden in Ireland. A study of National Cancer Registry Ireland data reported 643 cases in 2014, up from 434 in 1994, with 74.2% of patients male. These figures are old and cover all head and neck cancers, not only the patients this approval describes.
Frequently asked questions
What did the FDA approve on 5 November 2026?
Accelerated approval of Rybrevant Faspro as a single agent for adults with recurrent or metastatic head and neck squamous cell carcinoma, after platinum-based chemotherapy and an anti-PD-(L)1 antibody.
Who is not covered?
The drug is not indicated for HPV-associated oropharyngeal squamous cell carcinoma. The FDA decision covers later-line treatment, not first-line use.
Has it been shown to help patients live longer?
Not yet. The approval rests on response rate and duration of response. The FDA says long-term clinical benefit is not yet confirmed.
Can patients in Ireland get it for head and neck cancer?
It is not authorised in the EU for this use, and availability in Ireland is not known. This article is not medical advice. Nobody should change treatment without speaking to their doctor or pharmacist.
Is it made in Ireland?
The EU product information lists Ringaskiddy as one of two manufacturers of the active substance for Rybrevant. We could not confirm where the US product is made.
Outlook
Three things are worth watching. The first is whether J&J seeks an EU extension of indication, which would be the route to Ireland. The second is the full US prescribing information. The third is OrigAMI-5, with primary completion estimated for 18 June 2029. Until then, the case for the drug rests on tumour response rather than proven survival benefit. Priya Life Science will update this report if the EMA, J&J or the HSE publish further detail.
Sources
- US FDA, FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma, 5 November 2026
- US FDA, FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck squamous cell carcinoma, 5 November 2026
- Johnson & Johnson, Johnson & Johnson announces U.S. FDA approval of Rybrevant Faspro, 5 November 2026
- Johnson & Johnson, Rybrevant Faspro pivotal data show strong and durable responses in advanced head and neck cancer, 31 May 2026
- J&J Medical Connect, Use of Rybrevant Faspro in head and neck cancer: OrigAMI-4 study, accessed 6 November 2026
- PubMed, Burtness B et al, Pivotal Results From the Phase Ib/II OrigAMI-4 Study, Journal of Clinical Oncology, 20 August 2026
- ClinicalTrials.gov, NCT07276399, OrigAMI-5, record updated 3 November 2026
- ClinicalTrials.gov, NCT06385080, OrigAMI-4, accessed 6 November 2026
- European Medicines Agency, Rybrevant: EPAR, page updated 16 July 2026
- European Medicines Agency, Rybrevant product information, accessed 6 November 2026
- European Medicines Agency, CHMP agenda, 12 to 15 October 2026 and CHMP agenda, 14 to 17 September 2026
- National Centre for Pharmacoeconomics, Amivantamab (Rybrevant), HTA ID 24032, 11 March 2026
- National Centre for Pharmacoeconomics, Amivantamab with lazertinib, HTA ID 25006, 29 May 2026
- Johnson & Johnson Innovative Medicine Ireland, Our presence in Ireland, accessed 6 November 2026
- Sexton GP et al, European Archives of Oto-Rhino-Laryngology, The changing face of Irish head and neck cancer epidemiology: 20 years of data, published online 13 October 2021
Cover image: AI-generated illustration of a medicine carton and vial. It is not a photograph of the real product or its packaging.
