晚期乳腺癌:诺华公司的PI3K抑制剂Piqray获FDA授权

2019-05-25 不详 网络

诺华公司近日宣布,FDA批准了Piqray(alpelisib)与Faslodex(氟维司群)联合用于HR阳性、HER2阴性、PIK3CA突变的晚期或转移性乳腺癌患者(患者包括女性和男性),这些患者在基于内分泌的治疗方案后出现疾病进展。

诺华公司近日宣布,FDA批准了Piqrayalpelisib)与Faslodex(氟维司群)联合用于HR阳性、HER2阴性、PIK3CA突变的晚期或转移性乳腺癌患者(患者包括女性和男性),这些患者在基于内分泌的治疗方案后出现疾病进展。FDA药物评估和研究中心血液学和肿瘤学产品办公室主任Richard Pazdur评论道:“Piqray是第一种在治疗这类乳腺癌患者方面具有临床意义的PI3K抑制剂

这项批准得到了SOLAR-1试验的数据支持,该研究招募了572例符合要求的患者。在去年10月公布的研究结果中,与单独使用Faslodex相比,将Piqray添加到Faslodex可将死亡或疾病进展的风险降低35%。


原始出处:

http://www.firstwordpharma.com/node/1643129#axzz5ovUpnHnX

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    2019-10-30 仁医06
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    2020-05-10 jklm09
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