FDA grants Breakthrough Therapy Designation to Roche's inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
RHHBYRoche(RHHBY) globenewswire.com·2024-05-21 13:00

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 setting1 Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation and often face poorer prognosis and resistance to endocrine treatment2,3 This is the 29th Breakthrough Therapy Designation for Roche’s oncology portfolio, a testament to our enduring ambition to deliver transformative ...