Johnson & Johnson's RYBREVANT FASPRO™ Gains FDA Breakthrough Status for Advanced Head and Neck Cancer

FDA Breakthrough Therapy Designation

The U.S. FDA has granted Breakthrough Therapy Designation to subcutaneous amivantamab and hyaluronidase-lpuj for treating adults with HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma. This designation is for patients who have experienced disease progression after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

Targeting EGFR and MET Pathways

HPV-unrelated head and neck squamous cell carcinoma is marked by high rates of EGFR expression and MET pathway overexpression. Subcutaneous amivantamab is designed to target these pathways while activating the immune system, offering a potential new treatment option where current therapies are limited.

Clinical Study Results

The Breakthrough Therapy Designation is supported by data from the open-label Phase 1b/2 OrigAMI-4 study. This study demonstrated promising clinical activity, with a 45% overall response rate and a median duration of response of 7.2 months in a heavily pretreated patient population.

Ongoing Research

Further evaluation of subcutaneous amivantamab is underway in the Phase 3 OrigAMI-5 study. This study is assessing the subcutaneous formulation of amivantamab in combination with pembrolizumab and carboplatin versus 5-fluorouracil plus pembrolizumab and platinum-based chemotherapy as a first-line treatment for patients with HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma, regardless of PD-L1 expression.