Johnson & Johnson received FDA accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as a single-agent treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The approval covers disease that has progressed during or after platinum-based chemotherapy and anti-PD-(L)1 therapy. It excludes HPV-associated oropharyngeal squamous cell carcinoma.
This is Rybrevant Faspro’s first approved use beyond non-small cell lung cancer. The under-the-skin injection takes about five minutes to administer.
Approval was based on the Phase 1b/2 OrigAMI-4 study, which reported a 42% overall response rate, including 15% complete responses. Continued approval may depend on confirmatory clinical results.
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