FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for HNSCC
On November 5, 2026 the FDA granted accelerated approval to amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for adults with recurrent or metastatic HNSCC who progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval is based on an overall response rate of 42% (95% CI: 32%, 52%) in 102 patients, and the product is not indicated for HPV-associated oropharyngeal squamous cell carcinoma.
Primary source
FDA approval notification, November 5, 2026
FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck squamous cell carcinoma
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