Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration has accepted the company's New Drug Application and granted Priority Review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant.
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.
The FDA has set a Prescription Drug User Fee Act date of November 27, 2024.
The Priority Review is based on the positive Phase III INAVO120 results, which showed the inavolisib-based regimen more than doubled progression-free survival, reducing the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone in the first-line setting. Overall survival data were immature at the time of primary analysis, but a clear positive trend was observed.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.