Biotechnology company Halozyme Therapeutics Inc (Nasdaq:HALO) announced on Friday that Johnson & Johnson (NYSE:JNJ) was granted accelerated approval from the US 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.

This is the first approval of a dual-targeted therapy in this setting, simultaneously targeting epidermal growth factor receptor (EGFR)- and mesenchymal-epithelial transition (MET).

"This approval will further expand the reach of RYBREVANT FASPRO in a high unmet need population," said Dr. Helen Torley, president and CEO 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."

The indication does not include patients with oropharyngeal squamous cell carcinoma that is HPV-associated.