Bicara Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (CPS ≥1), excluding HPV-positive oropharyngeal squamous cell carcinoma. The designation is based on promising results from multiple Phase 1/1b cohorts, which demonstrated significant clinical benefit and a favorable safety profile. This regulatory milestone is intended to expedite the development and review of ficerafusp alfa, highlighting its potential to address an urgent unmet need in HPV-negative HNSCC. The grant was announced solely by Bicara Therapeutics Inc.