Cytori 旗下ATI-1123获得FDA孤儿药物认定

2018-09-18 MedSci MedSci原创

Cytori制药近日宣布,其候选药物ATI-1123(白蛋白稳定的聚乙二醇化脂质体多西紫杉醇)已经获得FDA孤儿药物认定,用于治疗小细胞肺癌。

Cytori制药近日宣布,其候选药物ATI-1123(白蛋白稳定的聚乙二醇化脂质体多西紫杉醇)已经获得FDA孤儿药物认定,用于治疗小细胞肺癌。美国FDA指定的孤儿药物旨在安全有效地治疗影响美国境内不到20万人的罕见疾病,FDA通过孤儿药物资格给予研发企业各种激励措施,包括临床试验的税收抵免,FDA批准后的7年营销专营权以及豁免处方药使用费等。

小细胞肺癌Small cell lung cancerSCLC)占支气管原发癌症的15%,2017年,美国境内共有33,375例新增病例和23,380例死亡病例。虽然SCLC患者对化学疗法和放射疗法有反应,但仅有约20%的患者实现了治愈,其余80%的患者,包括所有患有广泛疾病的患者,通常在完成初始治疗后数月内复发。SCLC的二线治疗方案的可用性也极其有限,并且在延长存活率方面提供的益处很少。拓扑替康是唯一获得FDA批准的SCLC二线治疗药物,其总有效率仅为24%,中位反应持续时间仅为14周,中位总生存期仅为25周。治疗通常包括连续5天的静脉注射或口服药物治疗,两者都有严重骨髓抑制的黑框警告。因此,对于不能耐受一线化疗/放疗的患者和接受拓扑替康的复发/难治患者,安全有效的新型制剂依然是远未满足的需求,而CytoriATI-1123有望填补这一空白。


原始出处:

http://www.firstwordpharma.com/node/1591375#axzz5RMgX4mDX

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    2018-09-20 随梦飞扬

    拓扑替康是唯一获得FDA批准的SCLC二线治疗药物,其总有效率仅为24%,中位反应持续时间仅为14周,中位总生存期仅为25周

    0

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    2018-09-18 医者仁心5538

    学习了

    0

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