Johnson & Johnson (J&J) has announced that the US Food and Drug Administration (FDA) has granted Priority Review (PR) 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. PR is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions and shortens the FDA review timeline to approximately 6 months.

Yusri Elsayed, MD, MHSc, PhD, Global Therapeutic Area Head, Oncology, J&J, said, “One of the hardest things about advanced head and neck cancer is that it can impact our most basic functions, like the ability to speak, eat, and even breathe easily, profoundly affecting patients’ daily lives. For those whose disease progresses despite prior treatment, that burden is compounded by limited treatment options and poor outcomes. Building on the established role of subcutaneous amivantamab in lung cancer, this milestone underscores its continued potential across multiple tumor types and reflects our commitment to bringing innovative treatment options to patients with cancers driven by EGFR and MET pathways.”

Subcutaneous amivantamab was designed to target both Epidermal Growth Factor Receptor (EGFR) and Mesenchymal-Epithelial Transition (MET) while engaging the immune system, offering a differentiated scientific approach in recurrent or metastatic HNSCC. Overexpression of EGFR and MET receptors is seen in 80 to 90 percent of HNSCC tumors and has been implicated in tumor progression and treatment resistance.

The FDA’s decision to grant PR is supported by results from the pivotal phase 1b/2 OrigAMI-4 study, which showed that 42 percent of patients responded to treatment with monotherapy subcutaneous amivantamab, with more than one-third of responders achieving a complete response. The study excluded patients with oropharyngeal squamous cell carcinoma caused by human papillomavirus (HPV), as well as those who had received prior anti-EGFR therapy. The findings were presented at the 2026 American Society for Clinical Oncology (ASCO) and published simultaneously in the Journal of Clinical Oncology.

RYBREVANT FASPRO is approved in over 40 countries, including the US, Europe, and Japan, as a subcutaneous treatment for Non-Small Cell Lung Cancer (NSCLC) and continues to be evaluated in additional tumor types as part of Johnson & Johnson’s broader commitment to advancing transformational oncology therapies.