Breakthrough Tag to Genentech Inavolisib for Hormone Receptor-Positive, HER2-Negative Breast Cancer

 

• The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
• Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation and often face poorer prognosis and resistance to endocrine treatment
• This is the 29th Breakthrough Therapy Designation for Genentech’s oncology portfolio, a testament to our enduring ambition to deliver transformative medicines for patients

https://www.biospace.com/article/releases/fda-grants-breakthrough-therapy-designation-to-genentech-s-inavolisib-for-advanced-hormone-receptor-positive-her2-negative-breast-cancer-with-a-pik3ca-mutation/