On November 6, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) (Halozyme) reported that Johnson & Johnson was granted accelerated approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE, 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 that is HPV-associated. 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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This approval will further expand the reach of RYBREVANT FASPRO in a high unmet need population," said 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."

For more information on this approval, please view Johnson & Johnson’s press release issued on November 5, 2026.

(Press release, Halozyme, NOV 6, 2026, View Source [SID1234674413])