13/10/2025 Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC (Ref) The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma. The

May 3rd Week, 2025 Regulatory Events 🎯 Incyte and MacroGenics, Inc.’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been approved by the US FDA for the first-line Tx of inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Retifanlimab has also been approved as a single agent for the Tx of locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemo. (Ref 1) ❓ What is the status of