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.
- – 優先審查認可了基於inavolisib的方案是對急需新的治療選擇的病人最有潛力的方案 –
- – INAVO120的額外分析將在2024年美國臨床腫瘤學會年會的口頭摘要中展示 –
- 美國FDA決策的目標行動日期爲2024年11月27日。
- 基於inavolisib的方案是在完成輔助內分泌治療12個月內局部晚期或轉移性、突變、激素受體(HR)陽性、人類表皮生長因子受體2(HER2)陰性的成人患者中評估的。PIK3CA-基於inavolisib的方案是在完成輔助內分泌治療12個月內局部晚期或轉移性、突變、激素受體(HR)陽性、人類表皮生長因子受體2(HER2)陰性的成人患者中評估的。