Posted by Michael Wonder on 13 Oct 2025
Bicara Therapeutics announces ficerafusp alfa granted breakthrough therapy designation by US FDA for first-line HPV negative metastatic or with unresectable, recurrent head and neck squamous cell carcinoma
13 October 2025 - Bicara Therapeutics today announced that the US FDA has granted breakthrough therapy designation to ficerafusp alfa in combination with pembrolizumab for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma whose tumours express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus positive oropharyngeal squamous cell carcinoma.
Breakthrough therapy designation was supported by results from multiple Phase 1/1b dose cohorts evaluating ficerafusp alfa in combination with pembrolizumab in patients with first-line HPV negative metastatic or with unresectable, recurrent head and neck squamous cell carcinoma.
