RARITAN, N.J., July 30, 2026
Johnson & Johnson has secured U.S. Food and Drug Administration Priority Review for a supplemental Biologics License Application (sBLA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as a potential treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The regulatory application covers patients whose cancer has progressed following platinum-based chemotherapy and treatment with a PD-1 or PD-L1 inhibitor. If approved for this indication, the subcutaneous therapy could provide a new targeted option for a patient population facing limited treatment choices and poor outcomes. FDA Priority Review is reserved for applications involving therapies that may provide significant improvements in the treatment of serious conditions and is designed to shorten the agency’s review timeline to approximately six months. The regulatory milestone expands the development potential of amivantamab beyond its established role in EGFR-mutated non-small cell lung cancer and highlights Johnson & Johnson’s strategy of evaluating the EGFR- and MET-targeted therapy across additional solid tumors.
Dual EGFR and MET Targeting Offers Differentiated Approach
RYBREVANT FASPRO is engineered to target both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (MET) while also engaging the immune system, providing a differentiated mechanism for recurrent or metastatic HNSCC. EGFR and MET are important biological drivers associated with tumor progression and treatment resistance, with overexpression of these receptors reported in a substantial proportion of head and neck squamous cell carcinoma tumors. This dual-targeted approach could be particularly important for patients whose disease continues to progress despite previous chemotherapy and immunotherapy. Head and neck squamous cell carcinoma is the most common form of head and neck cancer and can arise in areas including the mouth, throat, voice box, sinuses and nasal cavity. Advanced disease can significantly affect essential functions such as speaking, eating and breathing. Despite advances in surgery, radiation therapy, chemotherapy and immunotherapy, recurrent or metastatic disease continues to present a substantial therapeutic challenge.
OrigAMI-4 Data Support FDA Priority Review
The FDA Priority Review is supported by findings from the pivotal Phase 1b/2 OrigAMI-4 clinical study, which evaluated RYBREVANT FASPRO in recurrent or metastatic HNSCC. In the monotherapy cohort supporting the application, 42% of patients achieved an overall response to subcutaneous amivantamab, with more than one-third of responders achieving a complete response. The study evaluated patients previously treated with platinum-based chemotherapy and PD-1/PD-L1 immunotherapy, while excluding patients with HPV-positive oropharyngeal squamous cell carcinoma and those who had previously received anti-EGFR therapy. The treatment was administered weekly during the initial treatment period and subsequently every three weeks, with weight-based dosing adjustments. Overall response rate assessed using RECIST v1.1 criteria served as a primary endpoint across study cohorts. These clinical findings provide evidence supporting continued regulatory evaluation of subcutaneous amivantamab as a potential new treatment for advanced HNSCC.
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RYBREVANT Program Expands Across Solid Tumors
RYBREVANT FASPRO received U.S. FDA approval in December 2025 for certain EGFR-mutated non-small cell lung cancer treatment settings and is now approved across multiple international markets for NSCLC. The subcutaneous formulation combines amivantamab with recombinant human hyaluronidase, enabling delivery beneath the skin rather than through conventional intravenous administration. Johnson & Johnson continues to investigate RYBREVANT-based therapies across additional solid tumors, including head and neck and colorectal cancers. The latest Priority Review therefore represents an important regulatory expansion opportunity for the franchise. However, RYBREVANT FASPRO is not currently FDA-approved for recurrent or metastatic HNSCC, and the agency must complete its review before the therapy can be marketed for this indication. The combination of a differentiated EGFR/MET-targeted mechanism, encouraging OrigAMI-4 response data and expedited FDA review positions the program as an important development to watch in advanced head and neck cancer therapeutics.
Source: Johnson & Johnson press release
