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
罗氏基因泰克批准了美国食品药品管理局对Inavolisib与Palbociclib（Ibrance）和富尔维斯特朗联合使用的研究性口服疗法的优先审查
- – 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.
- – 优先审查认可了基于inavolisib的方案是对急需新的治疗选择的病人最有潜力的方案 –
- – INAVO120的额外分析将在2024年美国临床肿瘤学会年会的口头摘要中展示 –
- – FDA决定的目标行动日期为2024年11月27日 –
- 基于inavolisib的方案是在完成辅助内分泌治疗12个月内局部晚期或转移性、突变、激素受体(HR)阳性、人类表皮生长因子受体2(HER2)阴性的成人患者中评估的。PIK3CA-基于inavolisib的方案是在完成辅助内分泌治疗12个月内局部晚期或转移性、突变、激素受体(HR)阳性、人类表皮生长因子受体2(HER2)阴性的成人患者中评估的。