FDA approves Roche’s Inavolisib for Breast Cancer

USFDA has approved Inavolisib ((Itovebi) of Genentech in combination with palbociclib and fulvestrant, for the treatment of PIK3CA-mutated HR-positive HER2-negative breast cancer. As per Roche press release HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases. Genentech is a member of the Swiss Pharma major Roche Group.

The recommended inavolisib dose is 9 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity.

The Itovebi-based regimen was granted FDA Priority Review and Breakthrough Therapy Designation in May 2024. The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

Roche Press Release Itovebi