Relay's zovegalisib granted FDA Breakthrough Therapy Designation for PIK3CA-mutant breast cancer

Relay Therapeutics, Inc.

FDA granted Breakthrough Therapy Designation to zovegalisib + fulvestrant for PIK3CA-mutant HR+/HER2- advanced breast cancer after CDK4/6i.
Supported by ReDiscover trial data: 600mg BID fasted (N=52) and 400mg BID fed (N=57, Phase 3 dose) with comparable exposures.
Phase 3 dose 400mg BID fed data to be presented first at ESMO Targeted Anticancer Congress on March 16, 2026.
BTD aims to accelerate development and review; provides Fast Track features and enhanced FDA guidance.

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