新药|再获国际学术认可,恒瑞创新药吡咯替尼研究成果荣登柳叶刀·肿瘤学( 二 )


吡咯替尼是恒瑞医药自主研发且具有知识产权的口服表皮生长因子受体(HER1)/人表皮生长因子受体2(HER2)/人表皮生长因子受体4(HER4)酪氨酸激酶抑制剂 , 是原研HER1/HER2/HER4靶向药物 。 2018年 , 吡咯替尼凭借II期临床研究数据获国家药监局(NMPA)附条件批准上市 , 是实体瘤领域凭借II期临床研究获附条件批准上市的创新药 。 2019年 , 吡咯替尼被纳入国家医保 , 大大提升可及性和可负担性 。 2020年 , 吡咯替尼凭借两项重要III期研究(PHENIX、PHOEBE)结果获得国家药监局完全批准上市 。 目前 , 吡咯替尼还在进行涵盖乳腺癌、肺癌、胆道癌等多个瘤种的多项临床研究 , 持续探索不同疾病不同阶段的治疗方案 , 造福更多中国病患 。
参考文献:
[1] Yan M, Ouyang Q, Sun T, et al. Pyrotinib pluscapecitabine for patients with human epidermal growth factor receptor2-positive breast cancer and brain metastases (PERMEATE): a multicentre,single-arm, two-cohort,phase 2 trial. Lancet Oncol 2022; published online Jan24. https://doi.org/10.1016/S1470-2045(21)00716-6
[2] Bendell JC, Domchek SM, Burstein HJ, et al. Centralnervous system metastases in women who receive trastuzumab-based therapy formetastatic breast carcinoma. Cancer. 2003. 97(12): 2972-7
[3] Gori S, Rimondini S, De Angelis V, et al. Centralnervous system metastases in HER-2 positive metastatic breast cancer patientstreated with trastuzumab: incidence, survival, and risk factors. Oncologist.2007. 12(7): 766-73
[4] Brufsky AM, Mayer M, Rugo HS, et al. Central nervoussystem metastases in patients with HER2-positive metastatic breast cancer:incidence, treatment, and survival in patients from registHER. Clin Cancer Res.2011. 17(14): 4834-43
[5] Olson EM, Najita JS, Sohl J, et al. Clinical outcomesand treatment practice patterns of patients with HER2-positive metastaticbreast cancer in the post-trastuzumab era. Breast. 2013. 22(4): 525-31
【新药|再获国际学术认可,恒瑞创新药吡咯替尼研究成果荣登柳叶刀·肿瘤学】[6] Tanguturi S, Warren L. The Current and Evolving Roleof Radiation Therapy for Central Nervous System Metastases from Breast Cancer.Curr Oncol Rep. 2019. 21(6): 50