The U.S. FDA grants accelerated approval to Johnson & Johnson's Rybrevant Faspro for adults with advanced head and neck squamous cell carcinoma following prior chemotherapy and immunotherapy. The bispecific subcutaneous therapy targets EGFR and MET receptors, achieving a 42% overall response rate in Phase 1b/2 trials. The clearance expands Rybrevant beyond lung cancer, though HPV-associated cases are excluded. Johnson & Johnson must conduct an ongoing Phase 3 trial to confirm clinical benefits.
FDA approval details and requirements
- ▪The U.S. FDA granted accelerated approval to Johnson & Johnson's Rybrevant Faspro as a single-agent treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after standard chemotherapy and immunotherapy
- ▪The FDA approval of Rybrevant Faspro excludes patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma
- ▪The FDA's accelerated approval of Rybrevant Faspro requires Johnson & Johnson to conduct an ongoing Phase 3 clinical trial to confirm clinical benefit in head and neck cancer
Efficacy results in clinical trials
- ▪Among head and neck cancer patients responding to Rybrevant Faspro, 56% maintained their response for more than six months
- ▪In clinical trials evaluating head and neck cancer patients, Rybrevant Faspro demonstrated a 42% overall response rate, with 15% achieving a complete response
Mechanism and administration of Rybrevant Faspro
- ▪Rybrevant is a bispecific antibody designed to block EGFR and MET, two receptors overexpressed in certain cancers, to overcome single-target treatment resistance
- ▪Rybrevant Faspro utilizes Halozyme technology to enable subcutaneous injection in about five minutes, compared to two to five hours for intravenous Rybrevant infusions
Expansion beyond initial lung cancer indications
- ▪An ongoing Phase 3 confirmatory study for Rybrevant Faspro could support Rybrevant Faspro's potential expansion into first-line treatment for head and neck cancer
- ▪Intravenously infused Rybrevant received its initial FDA approval in 2021 for treating non-small cell lung cancers harboring an EGFR mutation
- ▪Rybrevant Faspro expands Johnson & Johnson's treatment indications beyond Rybrevant's previous FDA approvals in lung cancer
Product sales and financial projections
- ▪Johnson & Johnson has projected that the Rybrevant product franchise could reach $5 billion in peak sales
- ▪For the first nine months of 2026, Johnson & Johnson reported $866 million in global Rybrevant/Lazcluze sales, representing a 67.4% year-over-year increase
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