Posted by Michael Wonder on 22 May 2024
FDA grants breakthrough therapy designation to Roche’s inavolisib for advanced hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
21 May 2024 - The designation is based on Phase 3 INAVO120 results, showing the inavolisib based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting.
Roche announced today that the US FDA has granted breakthrough therapy designation for inavolisib, an investigational oral therapy, in combination with palbociclib and fulvestrant, for the treatment of adult patients with PIK3CA mutated, hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
