Roche: FDA approves breast cancer drug

(CercleFinance.com) - Roche announces that the US FDA has approved its Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, as a targeted therapy for hormone receptor-positive, HER2-negative advanced breast cancer with a PIK3CA mutation.


This approval is based on the results of the Phase III INAVO120 trial, showing that the Itovebi-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone in first-line treatment.

According to the Swiss laboratory, this decision addresses an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most frequently mutated genes in HR-positive diseases.


Copyright (c) 2024 CercleFinance.com. All rights reserved.