SAN DIEGO – November 06, 2026 -- The U.S. Food and Drug Administration granted Johnson & Johnson accelerated approval for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), a subcutaneous therapy co-formulated with Halozyme's ENHANZE technology, as a single agent for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), Halozyme Therapeutics (Nasdaq: HALO) announced.
FDA clears first dual-targeted therapy for post-chemotherapy, post-immunotherapy HNSCC
The indication covers adults whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. It excludes patients with HPV-associated oropharyngeal squamous cell carcinoma.
The approval is the first for a dual-targeted therapy in this setting. RYBREVANT FASPRO simultaneously targets epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), extending the product's dual-targeted profile beyond lung cancer.
Halozyme's ENHANZE platform gains a new oncology indication across a large licensee base
Halozyme CEO Helen Torley said the approval expands the product's reach in a "high unmet need population" and that ENHANZE is helping bring a new subcutaneous option to patients with advanced head and neck cancer.
ENHANZE has touched more than one million patient lives through ten commercialized products across more than 100 global markets. Licensees include Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb and argenx.
Johnson & Johnson issued its own release on the approval on November 5, 2026.