FDA grants accelerated approval to Johnson & Johnson's Rybrevant Faspro for advanced head and neck cancer
Johnson & Johnson's subcutaneous EGFR/MET-targeted therapy has received FDA accelerated approval for a defined population of adults with previously treated recurrent or metastatic head and neck squamous cell carcinoma.
The FDA granted accelerated approval on 5 November 2026 to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as monotherapy for adults whose recurrent or metastatic head and neck squamous cell carcinoma progressed on or after platinum-based chemotherapy and anti-PD-(L)1 treatment, excluding HPV-associated oropharyngeal squamous cell carcinoma.
The decision was supported by the Phase Ib/II OrigAMI-4 study, which reported a 42% overall response rate, and represents an accelerated approval requiring further confirmation of clinical benefit rather than unrestricted or traditional approval across all head and neck cancers.
Field | Content |
Article Type | Approvals |
Company | Johnson & Johnson |
Product | Rybrevant Faspro |
Active Ingredients | Amivantamab and hyaluronidase-lpuj |
Regulatory Authority | US Food and Drug Administration |
Approval Date | 5 November 2026 |
Approval Type | Accelerated approval |
Regulatory Status | FDA-approved for the specified head and neck cancer indication under the accelerated approval pathway |
Therapeutic Area | Oncology |
Cancer Type | Head and neck squamous cell carcinoma |
Abbreviation | HNSCC |
Approved Indication | Monotherapy for adults with recurrent or metastatic HNSCC progressing on or after platinum-based chemotherapy and anti-PD-(L)1 treatment |
Eligible Population | Adults with previously treated recurrent or metastatic HNSCC meeting the authorised treatment-history criteria |
Excluded Population | HPV-associated oropharyngeal squamous cell carcinoma |
Treatment Setting | Recurrent or metastatic disease after specified prior systemic therapies |
Treatment Regimen | Monotherapy |
Drug Modality | EGFR/MET-targeting antibody therapy with hyaluronidase |
Molecular Targets | EGFR and MET |
Administration Route | Subcutaneous |
Supporting Clinical Study | OrigAMI-4 |
Clinical Trial Phase | Phase Ib/II |
Reported Overall Response Rate | 42% |
Additional Efficacy Outcomes | Not specified in supplied summary |
Safety Findings | Not specified in supplied summary |
Confirmatory Evidence | Further confirmation of clinical benefit required under accelerated approval |
What Happened | The FDA granted accelerated approval to Rybrevant Faspro for a defined previously treated recurrent or metastatic HNSCC population. |
Why It Matters | The approval introduces an additional subcutaneous targeted treatment option for patients with advanced head and neck cancer after specified prior therapies. |
Clinical Significance | The 42% reported response rate supported accelerated approval in a population with limited remaining treatment options. |
Regulatory Clarification | The authorisation is accelerated rather than traditional approval and does not include HPV-associated oropharyngeal squamous cell carcinoma. |
Key Takeaway | Rybrevant Faspro received a new FDA accelerated approval for a restricted advanced head and neck cancer indication. |
What to Watch | Confirmatory clinical evidence, treatment adoption, safety monitoring and future regulatory developments. |
Primary Source | US Food and Drug Administration |
Primary Source URL | https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-treatment-head-and-neck-squamous-cell-carcinoma |
Relevant Date | 5 November 2026 |
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