RYBREVANT FASPRO (subcutaneous amivantamab and hyaluronidase-lpuj with Halozyme’s ENHANZE) - ( OrigAMI-4)
- Indication
- Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
- Stage
- phase6
- Event
- Approved
- Details
Nov. 6, 2026: Halozyme Therapeutics (NASDAQ: HALO) said Johnson & Johnson received FDA accelerated approval for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), co-formulated with Halozyme’s ENHANZE, as a single agent for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval excludes HPV-associated oropharyngeal squamous cell carcinoma.
The release says RYBREVANT FASPRO is the first dual-targeted therapy approved in this setting, targeting EGFR and MET, and describes it as a new subcutaneous treatment option for advanced head and neck cancer. Halozyme framed the event as an expansion of RYBREVANT FASPRO’s use beyond lung cancer and of ENHANZE’s reach. No efficacy or safety data were included in the provided content.
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