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  • FDA grants priority review to inavolisib for advan...

FDA grants priority review to inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

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Published:29th May 2024

Genentech, a member of the Roche Group , announced that the FDA 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 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 (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001) in the first-line setting. overall survival (os) data were immature at the time of primary analysis, but a clear positive trend was observed (stratified hr="0.64," 95% ci: 0.43-0.97, p="0.0338" [boundary of 0.0098]). follow-up for os is continuing to the next analysis.>

The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers. Early testing for mutations like PIK3CA prior to initiating first-line treatment can help identify people who may benefit from targeted therapy.

Based on the Priority Review designation, the FDA has set a Prescription Drug User Fee Act date of November 27, 2024. Data from INAVO120 are also being used for filing submissions to other global health authorities, including the European Medicines Agency.

Condition: Breast Cancer/HER2+ HER2-/PIK3CA
Type: drug

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