New Brunswick, USA: The US Food and Drug Administration (FDA) has granted accelerated approval to RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed following platinum-based chemotherapy and anti-PD-(L)1 antibody treatment.
Developed by Johnson & Johnson, the subcutaneous treatment is the first dual-targeted therapy approved for this patient group. It targets two pathways associated with tumour progression: epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET). The approval excludes patients with HPV-associated oropharyngeal squamous cell carcinoma.
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The decision was supported by results from the Phase 1b/2 OrigAMI-4 trial, which reported a confirmed overall response rate of 42%. Complete responses were observed in 15% of patients, while 28% experienced partial responses. Among those who responded, 56% maintained their response for more than six months.
“This approval represents a meaningful step forward for patients with head and neck squamous cell carcinoma, a disease where treatment options have historically been limited and outcomes remain poor,” said Angelo De Claro, M.D., director of the FDA’s Oncology Center of Excellence. “This therapy offers patients and their physicians a new option with the potential to make a real difference in people’s lives.”
The treatment is administered through a five-minute subcutaneous injection. The approval marks the first indication for RYBREVANT FASPRO beyond non-small cell lung cancer.
Continued approval may depend on confirmatory clinical trial results demonstrating clinical benefit. The ongoing Phase 3 OrigAMI-5 study is expected to provide further evidence.
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