FDA grants Priority Review to Roche's inavolisib in combination with palbociclib and fulvestrant for PIK3CA-mutated breast cancer based on INAVO120 trial results.

The FDA has granted Priority Review to Roche's inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant for patients with PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer. This review is based on the positive Phase III INAVO120 results, which demonstrated a 57% reduction in disease progression or death. The FDA decision target date is set for 27 November 2024.

May 29, 2024
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