Rybrevant Faspro
Stories
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FDA approves RYBREVANT FASPRO for advanced head and neck cancer
The FDA granted accelerated approval to RYBREVANT FASPRO, a co-formulated amivantamab and hyaluronidase-lpuj, for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval excludes patients with HPV-associated oropharyngeal squamous cell carcinoma.
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Johnson & Johnson announces FDA approval of RYBREVANT FASPRO for advanced head and neck cancer
The FDA granted accelerated approval for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) 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 is based on a 42 percent overall response rate (95 percent CI, 32-52 percent) from the Phase 1b/2 OrigAMI-4 trial.
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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.