美国食品药品监督管理局对晚期头癌的新组合疗法给予突破性地位. FDA grants breakthrough status to new combo therapy for advanced head neck cancer.

美国食品和药物管理局已授予Ficerafusp alfa,一类首个双功能抗体,与布罗利祖马布结合时,作为突破性治疗指标,用于转移或不可切除的复发性HPV阴性头平分细胞癌 (HNSCC) 和PD- L1CPS≥1的患者的第一线治疗. The FDA has granted Breakthrough Therapy Designation to ficerafusp alfa, a first-in-class bifunctional antibody, when combined with pembrolizumab, for first-line treatment of patients with metastatic or unresectable recurrent HPV-negative head and neck squamous cell carcinoma (HNSCC) and PD-L1 CPS ≥1. 该决定以第1/1b阶段试验数据为基础,显示总体存活率中位数为21.3个月,反应时间中位数为21.7个月,具有有利的安全特征,目的是加快发展和审查。 The decision, based on Phase 1/1b trial data showing a median overall survival of 21.3 months and median response duration of 21.7 months with a favorable safety profile, aims to accelerate development and review. Bicara治疗学正在推进关键的FORTIFI-HN01第2/3阶段试验,这是对大约650名病人进行的一项全球研究,其主要终点为总体反应率和总体存活率。 Bicara Therapeutics is advancing the pivotal FORTIFI-HN01 Phase 2/3 trial, a global study of about 650 patients, with primary endpoints of overall response rate and overall survival. 治疗以EGFR和PD-L1为目标,以改善肿瘤的渗透和反应,这种子型的治疗选择有限,结果不佳。 The therapy targets both EGFR and PD-L1 to improve tumor penetration and response in a subtype with limited treatment options and poor outcomes.