Subcutaneous Amivantamab Receives FDA Priority Review for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Clinical Summary:
- The FDA granted Priority Review to a supplemental Biologics License Application for subcutaneous amivantamab and hyaluronidase as treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed following platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
- The application was supported by results from the cohort 1 of the phase 1b/2 OrigAMI-4 trial, in which subcutaneous amivantamab produced an overall response rate of 42%. More than one-third of responders achieved a complete response.
- If approved, subcutaneous amivantamab would introduce a dual EGFR-and MET-targeted treatment for patients who have limited options after prior standard therapies.
The US Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application for subcutaneous amivantamab and hyaluronidase (RYBREVANT FASPRO™; Johnson & Johnson) for adult patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed following platinum-based chemotherapy and treatment with a PD-1 or PD-L1 inhibitor.
“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,” stated Yusri Elsayed, MD, PhD, global therapeutic area head at Johnson & Johnson. “For those whose disease progresses despite prior treatment, that burden is compounded by limited treatment options and poor outcomes.”
Subcutaneous amivantamab is a bispecific antibody designed to target epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) overexpression while promoting immune-mediated antitumor activity. According to Johnson & Johnson, EGFR and MET expression occurs in 80% to 90% of head and neck squamous cell carcinoma tumors and may contribute to tumor progression and treatment resistance.
The regulatory application was supported by findings from cohort 1 of the open-label, phase 1b/2 OrigAMI-4 trial, which evaluated subcutaneous amivantamab monotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma previously treated with platinum-based chemotherapy and PD-1 or PD-L1 immunotherapy. Patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma and those previously treated with anti-EGFR therapy were excluded from trial enrollment.
Patients received weight-based subcutaneous amivantamab weekly during the initial treatment period, followed by administration every 3 weeks. The primary end point was investigator-assessed overall response rate (ORR), according to RECIST version 1.1.
Subcutaneous amivantamab produced an ORR of 42%, with more than one-third of responders achieving a complete response. The company described the responses as rapid, deep, and durable, although additional response-duration and survival data were not included in the announcement.
Findings from OrigAMI-4 were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in the Journal of Clinical Oncology.
Priority Review shortens the FDA review period to approximately 6 months for therapies that may provide meaningful improvements in the treatment of serious conditions. The designation does not constitute regulatory approval.
Subcutaneous amivantamab and hyaluronidase is currently approved for several indications in EGFR-mutated non–small cell lung cancer. Its use in recurrent or metastatic head and neck squamous cell carcinoma remains investigational pending completion of the FDA review.
Source:
PR Newswire. Johnson & Johnson’s RYBREVANT FASPROTM (amivantamab and hyaluronidase-lpuj) receives US FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer. Accessed July 30, 2026. https://www.prnewswire.com/news-releases/johnson--johnsons-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-receives-us-fda-priority-review-as-potential-first-in-class-egfr--and-met-targeted-subcutaneous-treatment-for-advanced-head-and-neck-cancer-302838985.html
