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BeOne Medicines社、テビンブラ併用療法で米国FDAの優先審査指定を取得

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-- BeOne Medicines(ONC)は水曜日、テビンブラとジヘラおよび化学療法との併用療法に関する生物製剤承認申請(SBL)が、米国食品医薬品局(FDA)から優先審査指定を受けたと発表した。 この薬剤は、転移している、または手術で切除できない特定のタイプの胃がんまたは咽頭がんの患者を対象としている。特に、がんの増殖を促進するHER2と呼ばれるタンパク質が陽性の腫瘍を標的とする。 同社によると、併用療法の第3相臨床試験の中間データは申請を裏付けるものであり、テビンブラ併用療法は全生存期間および無増悪生存期間において統計的に有意な改善を示した。 BeOne Medicinesは、試験における併用療法の安全性に関する結果は、各成分の既知の効果と概ね一致していたと付け加えた。

Price: $296.42, Change: $-1.74, Percent Change: -0.58%

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