Bicara Therapeutics Secures Breakthrough Therapy Status for Ficerafusp Alfa
Bicara Therapeutics has 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 tumours are HPV-negative and express PD-L1 (CPS ≥1).
HPV-negative HNSCC represents the majority of head and neck cancer cases and is associated with poor outcomes and limited treatment options.
BTD recognises therapies that may offer substantial improvement over existing treatments, providing faster regulatory review, more interaction with the FDA, and eligibility for priority and rolling review.
Ficerafusp alfa is a first-in-class bifunctional antibody designed to improve tumour penetration by combining an EGFR-targeted monoclonal antibody with a domain that neutralises TGF-β signalling, overcoming barriers in the tumour microenvironment.
Early clinical data have shown deep and durable responses, with a median duration of response of 21.7 months and median overall survival of 21.3 months.
The drug is currently being evaluated in FORTIFI-HN01, a global Phase 2/3 pivotal trial enrolling approximately 650 patients to assess response rate, overall survival, progression-free survival, and duration of response.
BTD supports the development of this therapy with the aim of providing a new treatment option for patients with HPV-negative recurrent or metastatic HNSCC.
