New Brunswick, New Jersey, USA November 5, 2026
Johnson & Johnson (J&J) has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as a new treatment option for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The approval represents an important advancement in oncology, introducing the first and only dual-targeted therapy approved for this treatment setting. The subcutaneous formulation is indicated for adults whose cancer has progressed during or following platinum-based chemotherapy and anti-PD-(L)1 antibody treatment. The approval excludes patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma. RYBREVANT FASPRO simultaneously targets epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) pathways, two important biological mechanisms associated with tumor growth and progression. The treatment offers a new therapeutic approach for patients with advanced disease who have limited treatment options following previous therapies.
FDA Approval Supported by Promising Clinical Trial Results
The FDA’s accelerated approval was supported by clinically meaningful and durable responses demonstrated in the Phase 1b/2 OrigAMI-4 clinical trial. The study evaluated RYBREVANT FASPRO as a single-agent treatment in adults with previously treated recurrent or metastatic HNSCC. The pivotal Cohort 1 included 102 patients whose disease had progressed following platinum-based chemotherapy and anti-PD-(L)1 antibody treatment. Patients with HPV-associated oropharyngeal squamous cell carcinoma were excluded from this cohort. According to the clinical findings, the treatment achieved a confirmed overall response rate (ORR) of 42%, with a 95% confidence interval of 32% to 52%, as assessed by blinded independent central review. The results included complete responses in 15% of patients and partial responses in 28%. Furthermore, 56% of patients who responded to treatment maintained their responses for more than six months, demonstrating encouraging response durability. These findings were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology. The FDA had previously granted Breakthrough Therapy Designation to the treatment in February 2026, followed by Priority Review designation in July 2026. The latest approval highlights the potential of dual EGFR and MET inhibition in addressing difficult-to-treat head and neck cancers.
Dual-Targeted Mechanism Offers a New Treatment Approach
RYBREVANT FASPRO combines amivantamab, a fully human bispecific antibody, with recombinant human hyaluronidase PH20, enabling subcutaneous administration. The medicine is designed to target both EGFR and MET, which are key drivers of cancer progression and are overexpressed in approximately 80% to 90% of recurrent and metastatic HNSCC tumors. By simultaneously targeting these pathways, amivantamab works through multiple mechanisms, including blocking tumor growth signaling and directing immune-cell activity against cancer cells. An important advantage of the formulation is its administration through a subcutaneous injection that takes approximately five minutes, offering a different treatment delivery approach compared with conventional intravenous administration. The approval also marks the first indication for RYBREVANT FASPRO beyond non-small cell lung cancer (NSCLC), expanding the clinical application of amivantamab into another major oncology area. Johnson & Johnson expects this development to reinforce the potential of its targeted oncology portfolio across multiple difficult-to-treat solid tumors.
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Safety Profile and Confirmatory Clinical Development
The safety findings from the OrigAMI-4 study were generally consistent with the previously established safety profile of amivantamab, although clinically significant adverse reactions were reported. The most common adverse reactions occurring in at least 20% of patients included rash (79%), fatigue (39%), nail toxicity (35%), stomatitis (32%) and edema (28%). Serious adverse reactions occurred in 39% of patients, while fatal adverse reactions were reported in 6% of treated patients. Important warnings and precautions include hypersensitivity and administration-related reactions, interstitial lung disease or pneumonitis, dermatologic reactions, ocular toxicity and embryo-fetal toxicity. Healthcare professionals are advised to monitor patients carefully and follow the approved prescribing information. The FDA’s accelerated approval is based on overall response rate and duration of response, meaning continued approval may depend on confirmation of clinical benefit through additional studies. Johnson & Johnson is conducting the Phase 3 OrigAMI-5 confirmatory trial to further evaluate amivantamab-based treatment in recurrent or metastatic head and neck cancer. The study will provide additional evidence regarding the treatment’s clinical benefit in an earlier treatment setting. Overall, Johnson & Johnson’s FDA approval of RYBREVANT FASPRO represents a significant development in targeted cancer treatment. By combining dual EGFR and MET inhibition with convenient subcutaneous administration, the therapy introduces a new option for eligible patients with previously treated advanced head and neck cancer. The development also highlights the growing importance of precision oncology and targeted biologic therapies in addressing unmet medical needs across cancer treatment.
Source: Johnson & Johnson press release
