FDA批准诺华的Piqray用于治疗PIK3CA突变的晚期或转移性乳腺癌

2019-06-01 不详 MedSci原创

诺华的Piqray(alpelisib)与氟维司群联合,已获得美国食品和药物管理局(FDA)批准用于治疗HR +和HER2-PIK3CA突变的晚期或转移性乳腺癌的绝经后女性和男性。

诺华的Piqray(alpelisib)与氟维司群联合,已获得美国食品和药物管理局(FDA)批准用于治疗HR +和HER2-PIK3CA突变的晚期或转移性乳腺癌的绝经后女性和男性。

FDA的批准是基于一项III期试验SOLAR-1,其中在PIK3CA突变的HR + / HER2-晚期乳腺癌患者中,该组合的中位无进展生存期(PFS)从5.7个月增加到11个月,几乎翻了一番。

PIK3CA是HR + / HER2-乳腺癌中最常见的突变基因,约40%的患者存在突变,与肿瘤生长,对内分泌治疗的抵抗和整体预后不良有关。

Piqray通过抑制PI3K途径(主要是PI3K-α)发挥作用,以解决PIK3CA突变的影响,并可能有助于克服HR +晚期乳腺癌的内分泌抗性。

诺华肿瘤学首席执行官Susanne Schaffert说:"FDA批准Piqray标志着首次针对具有PIK3CA突变的HR + / HER2-晚期乳腺癌治疗。我们很自豪地提供一种新的治疗方案,以满足患有该突变患者的需求。"

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    2020-04-21 xinmeili
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    2019-06-16 仁医06
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