RYBREVANT FASPRO

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.

NEW BRUNSWICK, N.J. – November 06, 2026 -- The U.S. Food and Drug Administration has granted accelerated approval to Johnson & Johnson's RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), backed by a confirmed 42 percent overall response rate in a 102-patient cohort.

Approval covers post-platinum, post-immunotherapy patients and excludes HPV-associated oropharyngeal disease

The subcutaneous single-agent therapy is cleared for adults whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The indication excludes patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC). J&J says it is the first dual-targeted therapy approved in this setting, hitting both EGFR and MET, and describes it as the first advance in second-line treatment of the disease in a decade.