2021年4月2日,美国FDA授予不可逆FGFR口服抑制剂futibatinib(TAS-120)突破性疗法认定,用于治疗经治局部晚期或转移性胆管癌患者。这些患者携带FGFR2基因重排或融合。突破性疗法认定旨在加快治疗严重或危及生命的创新疗法的开发和审评过程。 这一突破性疗法认定的授予基于一项II期FOENIX-CCA2临床试验的结果。在去年欧洲肿瘤内科学会亚洲大会(ESMO Asia)上公布的中期数据分析显示,在67名随访时间超过6个月、携带FGFR2基因融合或重排的肝内胆管癌患者中,futibatinib达到37.3%的客观缓解率(ORR),82.1%的疾病控制率(DCR),中位缓解持续时间(DoR)达到8.3个月,中位无进展生存期(PFS)达到7.2个月。 不同亚组的患者均出现客观缓解,且在年龄超过65岁的患者亚群中,ORR达到57.1%。这一临床试验的最新结果将在今年4月举行的AACR年会上公布。 参考资料:[1]Ronan J.Kelly,Jaffer A.Ajani,Jaroslaw Kuzdzal,et al.Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.published on April 1,2021.doi:10.1056/NEJMoa2032125.[2]Y.Yue,J.Hur,Y.Cao,et al.Prospective Evaluation of Dietary and Lifestyle Pattern Indices with Risk of Colorectal Cancer in a Cohort of Younger Women.published on March 31,2021.doi:https://doi.org/10.1016/j.annonc.2021.03.200.[3]Nuria Chic,Stephen J Luen,Paolo Nuciforo,et al.Tumor Cellularity and Infiltrating Lymphocytes(CelTIL)as a Survival Surrogate in HER2-Positive Breast Cancer.published on March 31,2021.doi:https://doi.org/10.1093/jnci/djab057.[4]FDA Grants Breakthrough Therapy Designation for Taiho Oncology's Futibatinib for Treatment of Advanced Cholangiocarcinoma.Retrieved April 1,2021,fromhttps://www.prnewswire.com/news-releases/fda-grants-breakthrough-therapy-designation-for-taiho-oncologys-futibatinib-for-treatment-of-advanced-cholangiocarcinoma-301260615.html