Bicara Thera earns FDA Breakthrough status for ficerafusp alfa

Boston, USA-based Bicara Therapeutics (Nasdaq: BCAX), a biotech focused on developing bifunctional therapies for solid tumors, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for. its ficerafusp alfa in combination with Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab). The news pushed Bicara’s shares up 4.5% to $18.59.

The designation is for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma.

The company said this designation from the FDA underscores the growing recognition of HPV-negative HNSCC as a distinct clinical indication within head and neck cancer – one with particularly poor outcomes, limited therapeutic options, and that represents the vast majority of patients.