Posted by Michael Wonder on 03 Feb 2026
Relay Therapeutics announces zovegalisib granted breakthrough therapy designation by US FDA for PIK3CA mutant, HR+/HER2- advanced breast cancer
3 February 2026 - Designation supported by robust clinical data from ReDiscover trial with 600mg BID fasted and 400mg BID fed doses of zovegalisib in combination with fulvestrant.
Relay Therapeutics today announced that the US FDA has granted breakthrough therapy designation to zovegalisib (RLY-2608) in combination with fulvestrant for the treatment of adults with PIK3CA mutant, hormone receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
