创新靶向药RET抑制剂Pralsetinib扩展适应症获美国FDA批准,用于治疗甲状腺癌

2020-12-03 医谷网 医谷网

近日,美国食品药品监督管理局(FDA)加速批准了创新靶向药RET抑制剂普拉替尼(pralsetinib)的扩展适应症,用于治疗携带RET变异的甲状腺癌患者。这是肿瘤精准治疗领域的又一重要里程碑。

近日,美国食品药品监督管理局(FDA)加速批准了创新靶向药RET抑制剂普拉替尼(pralsetinib)的扩展适应症,用于治疗携带RET变异的甲状腺癌患者。这是肿瘤精准治疗领域的又一重要里程碑。

普拉替尼由Blueprint Medicines公司开发,是一种口服、每日一次、强效高选择性RET抑制剂。目前,美国FDA已批准该款药物3个适应症,分别为用于治疗RET融合阳性非小细胞肺癌(NSCLC)成人患者、12岁以上需要全身治疗的晚期或转移性RET突变甲状腺髓样癌(MTC)患者和需要全身治疗且放射性碘难治性晚期或转移性RET融合阳性甲状腺癌患者。此外,普拉替尼已被FDA授予“突破性疗法认定”。

据了解,普拉替尼在大中华地区的开发和商业化的权益则由基石药业拥有。目前,我国国家药品监督管理局已于今年9月4日受理了普拉替尼作为国家1.1类新药的上市申请,并将其纳入优先审评,用于治疗经含铂化疗的RET融合阳性的非小细胞肺癌患者。值得一提的是,今年9月30日,普拉替尼成功引入海南自由贸易港博鳌乐城国际医疗旅游先行区,这是该药物在美国之外仅有的落地市场,国内患者可以优先在博鳌乐城申请使用。

此外,基石药业还在中国开展了普拉替尼一线治疗RET融合的NSCLC和甲状腺髓样癌的注册临床研究,同时普拉替尼在其他携带RET变异的晚期实体瘤的疗效也在进一步探索中。目前,普拉替尼在甲状腺髓样癌、甲状腺癌、非小细胞肺癌等多种RET突变的晚期实体瘤患者中都已展示出广泛而持久的抗肿瘤活性,潜力无限。期待创新靶向药RET抑制剂普拉替尼在国内能够早日获批上市,尽早惠及更多患者。

精准治疗:RET抑制剂实现甲状腺癌重磅突破

在我国,甲状腺癌发病率逐年上升。相关报告显示,甲状腺癌发病率约为14.6/10万人,其中甲状腺髓样癌(MTC)发病率约占甲状腺癌的2%-4%,其恶性程度较高,易发生远处转移,且晚期患者疗效不佳。约60%的甲状腺髓样癌可检测出RET基因突变,晚期患者的RET突变比例更高达90%。RET基因突变可谓是甲状腺髓样癌的“万恶之源”,对于存在90%RET突变的晚期甲状腺髓样癌,精准抑制RET突变将至关重要,这将会进一步提高肿瘤缓解率,改善患者预后。

创新靶向药普拉替尼的“诞生”打破了甲状腺髓样癌(MTC)多靶点“撒网”的局面,它可以高选择性、精准打击RET突变基因,对携带RET突变的甲状腺髓样癌(MTC)晚期患者具有更广泛和持久的抗肿瘤作用,而且通过抑制原发和继发突变,普拉替尼有望克服和预防临床耐药的发生。

精准治疗:RET融合非小细胞肺癌迎新生机

除了甲状腺癌领域,在肺癌领域,普拉替尼也将为RET融合非小细胞肺癌患者提供新的生机。目前,在这一领域,EGFR、ALK、ROS1等驱动基因突变已广泛普及,针对这些驱动基因的靶向药物均已获批上市。RET融合是新近发现的肺癌驱动基因,在非小细胞肺癌中RET融合患者约占1- 2% ,以非吸烟人群较为常见。以肺癌的庞大患者基数估算,中国每年新发RET阳性肺癌患者约1.1万人。对于RET突变的患者来说,患者拥有其他致癌性驱动基因的可能性低,被诊断时大都已处于疾病晚期,这给诊疗带来了极大的挑战。

目前,RET融合非小细胞肺癌的标准治疗仍以化疗为主,但疗效并不理想,尚存在巨大的未被满足的临床治疗需求。普拉替尼作为专为RET基因变异肿瘤患者而研发的高选择性RET抑制剂,将为RET融合非小细胞肺癌患者提供新的生机。

作为一家专注于开发及商业化创新肿瘤免疫治疗及精准治疗药物的生物制药公司,基石药业已集结了一支在新药研发、临床研究以及商业化方面拥有丰富经验的世界级管理团队。目前,基石药业已建立了一条16种肿瘤候选药物组成的丰富产品管线,其中5款后期候选药物正处于关键性临床试验或注册阶段。凭借经验丰富的管理团队、丰富的管线、专注于临床开发的业务模式和充裕资金,基石药业的愿景是成为享誉全球的生物制药公司,引领攻克癌症之路。

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    2021-11-08 bugit
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    2021-01-10 ysjykql
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    2021-09-21 jklm09
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    2020-12-03 ms6000001515816393

    0

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    2020-12-03 飞翔的乌龟

    0

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