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February 4, 2026

Relay Therapeutics’ zovegalisib secures FDA BTD for advanced breast cancer

Relay Therapeutics has received the US Food and Drug Administration (FDA) breakthrough therapy designation (BTD) for zovegalisib (RLY-2608), along with fulvestrant, for human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer treatment.

The application featured clinical data for two dosing regimens: 400mg BID fed (n=57) and 600mg BID fasted (n=52). Credit: Joeahead / Shutterstock.com.