Global Finance News
07 Nov 2026, 11:31
Johnson & Johnson Wins FDA Approval for Rybrevant Faspro in Advanced Head and Neck Cancer
Johnson & Johnson (NYSE: JNJ) said the U.S. FDA granted accelerated approval to Rybrevant Faspro as a single-agent treatment for certain adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum chemotherapy and an anti-PD-(L)1 therapy.
The approval is the first for a dual EGFR- and MET-targeted therapy in this treatment setting and marks Rybrevant Faspro’s first indication beyond non-small cell lung cancer. The therapy is administered as a subcutaneous injection.
FDA clearance was supported by the Phase 1b/2 OrigAMI-4 study, where the confirmed overall response rate was 42%, including complete responses in 15% of patients. Among responders, 56% maintained their response for more than six months.
The indication excludes HPV-associated oropharyngeal squamous cell carcinoma, and continued approval may depend on confirmation of clinical benefit in the ongoing Phase 3 OrigAMI-5 study.
The approval broadens Johnson & Johnson’s oncology franchise by extending amivantamab into another difficult-to-treat solid tumor and could increase the commercial opportunity for the Rybrevant platform beyond lung cancer.
Johnson & Johnson (NYSE: JNJ) said the U.S. FDA granted accelerated approval to Rybrevant Faspro as a single-agent treatment for certain adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum chemotherapy and an anti-PD-(L)1 therapy.
The approval is the first for a dual EGFR- and MET-targeted therapy in this treatment setting and marks Rybrevant Faspro’s first indication beyond non-small cell lung cancer. The therapy is administered as a subcutaneous injection.
FDA clearance was supported by the Phase 1b/2 OrigAMI-4 study, where the confirmed overall response rate was 42%, including complete responses in 15% of patients. Among responders, 56% maintained their response for more than six months.
The indication excludes HPV-associated oropharyngeal squamous cell carcinoma, and continued approval may depend on confirmation of clinical benefit in the ongoing Phase 3 OrigAMI-5 study.
The approval broadens Johnson & Johnson’s oncology franchise by extending amivantamab into another difficult-to-treat solid tumor and could increase the commercial opportunity for the Rybrevant platform beyond lung cancer.
