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Priority Review reinforces the significant potential of subcutaneous amivantamab in recurrent or metastatic head and neck cancer, where the current five-year survival rate is only 15 percent
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Patients achieved rapid, deep and durable responses, including a 42 percent overall response rate with one-third achieving a complete response
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Subcutaneous amivantamab is the only therapy in head and neck cancer engineered to target both EGFR and MET, proven drivers of tumor growth and treatment resistance
RARITAN, N.J., July 30, 2026 – Johnson & Johnson (NYSE:JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for subcutaneous amivantamab and hyaluronidase-lpuj for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). If approved, it would provide a new treatment for patients whose disease has progressed following platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions and shortens the FDA review timeline to approximately six months.1
“One of the hardest things about advanced head and neck cancer is that it can impact our most basic functions, like the ability to speak, eat, and even breathe easily, profoundly affecting patients’ daily lives. For those whose disease progresses despite prior treatment, that burden is compounded by limited treatment options and poor outcomes,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “Building on the established role of subcutaneous amivantamab in lung cancer, this milestone underscores its continued potential across multiple tumor types and reflects our commitment to bringing innovative treatment options to patients with cancers driven by EGFR and MET pathways.”
Subcutaneous amivantamab was designed to target both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) while engaging the immune system, offering a differentiated scientific approach in recurrent or metastatic head and neck squamous cell carcinoma.2 Overexpression of EGFR and MET receptors is seen in 80 to 90 percent of head and neck squamous cell carcinoma tumors and has been implicated in tumor progression and treatment resistance.3
Priority Review supported by pivotal results
The FDA’s decision to grant Priority Review is supported by results from the pivotal Phase 1b/2 OrigAMI-4 study, which showed that 42 percent of patients responded to treatment with monotherapy subcutaneous amivantamab, with more than one-third of responders achieving a complete response. The study excluded patients with oropharyngeal squamous cell carcinoma caused by human papillomavirus (HPV), as well as those who had received prior anti-EGFR therapy. The findings were presented at the 2026 American Society for Clinical Oncology (ASCO) and published simultaneously in the Journal of Clinical Oncology.4,5
RYBREVANT FASPRO™ is approved in more than 40 countries, including the United States, Europe, and Japan, as a subcutaneous treatment for non-small cell lung cancer and continues to be evaluated in additional tumor types as part of Johnson & Johnson’s broader commitment to advancing transformational oncology therapies.
About the OrigAMI-4 Study
OrigAMI-4 (NCT06385080) is an open-label Phase 1b/2 study evaluating RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The study includes six cohorts exploring RYBREVANT FASPRO™ across different treatment settings and regimens.
Cohort 1 evaluated RYBREVANT FASPRO™ as monotherapy in patients with R/M HNSCC who had received prior platinum-based chemotherapy and PD-1/PD-L1 immunotherapy. Patients with HPV-positive oropharyngeal squamous cell carcinoma were excluded, as well as those with prior anti-EGFR therapy.
RYBREVANT FASPRO™ was administered on a weekly schedule during the initial treatment period followed by dosing every three weeks (Q3W), with weight-based dosing adjustments. The primary endpoint across cohorts is overall response rate (ORR), as assessed by investigators, using RECIST v1.1.† 6
About Head and Neck Squamous Cell Carcinoma
Head and neck squamous cell carcinoma (HNSCC) is the most common form of head and neck cancer, a group of cancers that arise in the mouth, throat, voice box, sinuses, nasal cavity, and salivary glands.7 It represents approximately 4.5 percent of all cancers worldwide and is the seventh most common cancer globally.7 Major risk factors include tobacco and alcohol use, as well as infection with high-risk human papillomavirus (HPV).7 Approximately 80 percent of recurrent or metastatic HNSCC are not driven by HPV, and are typically associated with poorer prognosis and reduced response to treatment.7,8,9 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients ultimately progress to advanced recurrent or metastatic disease.10,11
About RYBREVANT FASPRO™ and RYBREVANT®
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE® (lazertinib) or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients, RYBREVANT FASPRO™ offers a once-monthly dosing option following initial weekly dosing. RYBREVANT FASPRO™ is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.
RYBREVANT FASPRO™ is approved in the U.S. for the same indications as intravenous RYBREVANT® (amivantamab-vmjw) across multiple markets. RYBREVANT® is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.
The effectiveness of RYBREVANT FASPRO™ is supported by the established clinical profile of RYBREVANT®, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE® in first-line advanced EGFR-mutated NSCLC.
The National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)‡ 12 include amivantamab-vmjw (RYBREVANT®) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE®) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO™) may be substituted for IV amivantamab-vmjw (RYBREVANT®) where appropriate. See the latest NCCN Guidelines® for NSCLC for complete information.§ ||
The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT®)-based regimens, including in combination with lazertinib (LAZCLUZE®), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.§ ||
Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.
The legal manufacturer for RYBREVANT FASPRO™ and RYBREVANT® is Janssen Biotech, Inc.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
† RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well
solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.
‡ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
§ See the NCCN Guidelines for detailed recommendations, including other treatment options.
|| The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.
Footnotes
1 U.S. Food & Drug Administration. Priority Review. Accessed July 2026. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
2 Harrington KJ, Rosenberg AJ, Yang MH, et al. Subcutaneous amivantamab in recurrent/metastatic head and neck squamous cell cancer after disease progression on checkpoint inhibitor and chemotherapy: Preliminary results from the phase 1b/2 OrigAMI-4 study. Oral Oncol. 2025;171:107791.
3 Kalyankrishna S, Grandis JR. Epidermal growth factor receptor biology in head and neck cancer. J Clin Oncol. 2006;24(17):2666–2672.
4 Burtness B, Rosenberg AJ, Calderon B, et al. Amivantamab in recurrent/metastatic head and neck squamous cell cancer after disease progression on immune checkpoint inhibitor and chemotherapy. Pivotal results from the phase 1b/2 OrigAMI-4 study. Presented at: The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31, 2026; Chicago, Illinois.
5 Burtness B, Rosenberg AJ, Calderon B, et al. Amivantamab in recurrent/metastatic head and neck squamous cell carcinoma after checkpoint inhibitor and chemotherapy: pivotal results from the phase 1b/2 OrigAMI-4 study. J Clin Onc. May 31, 2026. doi:10.1200/JCO-26-01042.
6ClinicalTrials.gov. A study of amivantamab alone or in addition to other treatment agents in participants with recurrent/metastatic head and neck cancer (OrigAMI-4). Accessed July 2026. https://clinicaltrials.gov/study/NCT06385080?term=OrigAMI-4&limit=10&rank=1.
7Barsouk A, Aluru JS, Rawla P, Saginala K, Barsouk A. Epidemiology, risk factors, and prevention of head and neck squamous cell carcinoma. Med Sci (Basel). 2023;11(2):42. Published 2023 Jun 13. doi:10.3390/medsci11020042
8Haddad RI, Ferrarotto R, Guo Y, et al. OrigAMI-5: A randomized, phase 3 study of amivantamab plus pembrolizumab and carboplatin vs standard of care pembrolizumab plus platinum and 5-fluorouracil as first-line treatment in recurrent/metastatic head and neck cancer. Presented at: The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30, 2026; Chicago, Illinois.
9 Ghiani L, Chiocca S. High risk-human apillomavirus in HNSCC: Present and future challenges for pigenetic therapies. Int J Mol Sci. 2022;23(7):3483. doi.org/10.3390/ijms23073483
10 Ferris RL, Blumenschein Jr G, Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and eck. New Eng J Med. 2016;375(19):1856-1867. doi:10.1056/NEJMoa1602252
11Wise-Draper TM, Bahig H, Tonneau M, Karivedu V, Burtness B. Current therapy for metastatic head and neck ancer: Evidence, opportunities, and challenges. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_350442
12 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2026 © National Comprehensive Cancer Network, Inc. All rights reserved. Accessed July 2026.To view the most recent and complete version of the guideline, go online to NCCN.org.
13 RYBREVANT FASPRO [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
14 RYBREVANT [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.