Genentech, a Roche Group (RHHBY) subsidiary, has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application for inavolisib and granted it Priority Review. This investigational oral therapy is intended for use in combination with palbociclib (Ibrance) and fulvestrant.
The inavolisib-based regimen has been 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. These patients experienced disease recurrence either during or within 12 months of completing adjuvant endocrine therapy.
The FDA has scheduled the Prescription Drug User Fee Act (PDUFA) date for November 27, 2024.
The Priority Review designation stems from positive results in the Phase III INAVO120 trial. The findings revealed that the inavolisib-based regimen more than doubled progression-free survival, reducing the risk of disease progression or death by 57% compared to the combination of palbociclib and fulvestrant alone in the first-line setting. Although overall survival data were still immature at the time of the primary analysis, there was a clear positive trend.
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