Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer
PR Newswire
RARITAN, N.J., July 30, 2026
Priority Review reinforces the significant potential of subcutaneous amivantamab in recurrent or metastatic head and neck cancer, where the current five-year survival rate is only 15 percent Patients achieved rapid, deep and durable responses, including a 42 percent overall response rate with one-third achieving a complete response Subcutaneous amivantamab is the only therapy in head and neck cancer engineered to target both EGFR and MET, proven drivers of tumor growth and treatment resistance RARITAN, N.J., July 30, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for subcutaneous amivantamab and hyaluronidase-lpuj for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). If approved, it would provide a new treatment for patients whose disease has progressed following platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions and shortens the FDA review timeline to approximately six months.1
