Johnson & Johnson’s RYBREVANT FASPRO™ Receives FDA Breakthrough Therapy Designation for Advanced Head and Neck Cancer
Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is unrelated to human papillomavirus (HPV), following progression on platinum-based chemotherapy and PD-1/PD-L1 inhibitors.
The subcutaneous therapy targets both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) pathways while engaging the immune system.
Early data from the Phase 1b/2 OrigAMI-4 study showed rapid and durable responses in heavily pretreated patients.
RYBREVANT FASPRO™ is now being evaluated in the ongoing Phase 3 OrigAMI-5 trial (NCT07276399) in combination with pembrolizumab and carboplatin as a potential first-line treatment for HPV-unrelated recurrent or metastatic HNSCC.
The FDA’s Breakthrough Therapy Designation is intended to accelerate the development and review of medicines for serious conditions where early evidence suggests meaningful improvement over existing options.
RYBREVANT FASPRO™ is already approved in multiple settings for EGFR-mutated non-small cell lung cancer.
