Roche's Genentech Granted Priority Review By FDA For Inavolisib, An Investigational Oral Therapy, In Combination With Palbociclib (Ibrance) And Fulvestrant
Roche's Genentech Granted Priority Review By FDA For Inavolisib, An Investigational Oral Therapy, In Combination With Palbociclib (Ibrance) And Fulvestrant
羅氏基因泰克批准了美國食品藥品管理局對Inavolisib與Palbociclib（Ibrance）和富爾維斯特朗聯合使用的研究性口服療法的優先審查
- – Priority Review recognizes the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options –
- – Additional analyses of INAVO120 will be presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting –
- – The target action date for the FDA decision is November 27, 2024 –
- The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
- — Priority Review認識到，對於迫切需要新治療選擇的患者而言，基於inavolisib的療法具有一流的潛力—
- — 對 INAVO120 的更多分析將在2024年美國臨床腫瘤學會年會的口頭摘要會議上公佈—
- — 美國食品藥品管理局決定的目標行動日期是2024年11月27日—
- 對基於inavolisib的治療方案在成年患者中進行了評估 PIK3CA-突變、激素受體 (HR)-陽性、人類表皮生長因子受體 2 (HER2)-陰性、局部晚期或轉移性乳腺癌，在完成輔助內分泌治療後或在完成輔助內分泌治療後 12 個月內復發。
譯文內容由第三人軟體翻譯。
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