U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with Halozyme's ENHANZE® Technology for the Treatment of Advanced Head and Neck Cancer
PR Newswire•06/11/2026•09:57 ET
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Key Highlights
- ➤FDA grants accelerated approval for RYBREVANT FASPRO in advanced head and neck cancer
- ➤Approval covers recurrent or metastatic HNSCC after platinum chemotherapy and anti-PD-(L)1 treatment
- ➤RYBREVANT FASPRO is the first dual-targeted therapy approved in this setting
- ➤Halozyme’s ENHANZE technology enables the subcutaneous co-formulated treatment
- ➤ENHANZE has reached more than one million patients through ten commercialized products
Expert Statements
Dr. Helen Torley, President and Chief Executive Officer of Halozyme
“This approval will further expand the reach of RYBREVANT FASPRO in a high unmet need population”
Dr. Helen Torley, President and Chief Executive Officer of Halozyme
“We are pleased that our ENHANZE technology is helping bring a new subcutaneous treatment option to patients with advanced head and neck cancer”
U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with Halozyme's ENHANZE® Technology for the Treatment of Advanced Head and Neck Cancer PR Newswire
Approval extends RYBREVANT FASPRO's well-established, dual-targeted benefit beyond lung cancer
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