Posted by Michael Wonder on 30 May 2024
FDA grants priority review to Roche’s inavolisib for advanced hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
29 May 2024 - The target action date for the FDA decision is 27 November 2024.
Roche announced today that the US FDA has accepted the company’s new drug application and granted priority review to inavolisib, an investigational, oral therapy, in combination with palbociclib (Ibrance) and fulvestrant.
