Johnson and Johnson’s RYBREVANT FASPRO earns US FDA Priority Review as a potential first-in-class EGFR and MET-targeted subcutaneous therapy for advanced head and neck cancer

Johnson and Johnson has recently announced that the US FDA has granted Priority Review to a supplemental Biologics License Application for subcutaneous amivantamab and hyaluronidase-lpuj in adults with recurrent or metastatic head and neck squamous cell carcinoma. A successful outcome would deliver a fresh treatment avenue for patients whose disease has worsened after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. Priority Review is reserved for medicines with the potential to offer meaningful gains in safety or effectiveness in serious conditions and compresses the standard FDA review window to approximately six months.

“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,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson and Johnson. “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 engineered to simultaneously engage both the epidermal growth factor receptor and mesenchymal-epithelial transition receptor while also recruiting the immune system, bringing a scientifically distinct approach to recurrent or metastatic head and neck squamous cell carcinoma. Elevated expression of EGFR and MET receptors is a feature of 80 to 90% of head and neck squamous cell carcinoma tumours and has been closely linked to both tumour advancement and the emergence of resistance to existing treatments.

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Related Topics and Keywords

egfr, Johnson and Johnson's, MET-targeted subcutaneous therapy, neck cancer, RYBREVANT FASPRO