Johnson & Johnson announces U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer
Key Highlights
- ➤FDA grants accelerated approval for RYBREVANT FASPRO in recurrent or metastatic HNSCC
- ➤OrigAMI-4 confirmed 42% overall response rate, including 15% complete responses
- ➤56% of responders maintained responses beyond six months
- ➤Approval marks first dual EGFR- and MET-targeted therapy in this setting
- ➤Continued approval may depend on confirmatory Phase 3 OrigAMI-5 results
Expert Statements
Amanda Hollinger, Executive Director, Head and Neck Cancer Alliance
“At a time when treatment advances are urgently needed to improve outcomes for patients, this new option offers renewed hope for patients and their families.”
Barbara Burtness, M.D., Medical oncologist and professor of medicine at Yale Cancer Center
“The OrigAMI-4 findings represent important progress and highlight the potential of dual EGFR- and MET-targeting with amivantamab as a distinct treatment approach in recurrent or metastatic head and neck cancer, excluding HPV-associated oropharyngeal squamous cell carcinoma. The meaningful responses observed in this study are encouraging for patients who have long faced limited treatment options.”
Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson
“RYBREVANT FASPRO delivers a differentiated approach, targeting both EGFR and MET to address the biology that drives this disease. Having redefined outcomes in EGFR+ non-small cell lung cancer, we are unlocking the next chapter of this treatment and bringing meaningful innovation to patients with certain head and neck cancers.”
Johnson & Johnson announces U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer PR Newswire
* Accelerated approval based on data demonstrating clinically meaningful efficacy, including a 42 percent overall response rate (95 percent confidence interval, 32–52 percent)(1) * First advancement in the second-line treatment setting for recurrent or metastatic head and neck cancer in a decade, bringing a new subcutaneous option to patients with significant unmet need(2-3) * Extending its well-established, dual-targeted benefit beyond lung cancer, RYBREVANT FASPRO™ targets both EGFR and MET pathways – two key drivers of tumor progression in head and neck cancer(2) NEW BRUNSWICK, N.J., Nov. 5, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) (subcutaneous injection, 160 mg/2,000 units per mL) as a single agent for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum–based chemotherapy and an anti–PD–(L)1 antibody. The indication does not include patients with oropharyngeal squamous cell carcinoma (OPSCC) that is HPV-associated (i.e., by p16 immunohistochemistry). It is the first approval of a dual-targeted therapy in this setting, simultaneously targeting epidermal growth factor receptor (EGFR)- and mesenchymal-epithelial transition (MET).(2-3)
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