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Relay Therapeutics Announces Zovegalisib Granted Breakthrough Therapy Designation by U.S. FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer
Designation supported by robust clinical data from ReDiscover trial with 600mg BID fasted and 400mg BID fed doses of zovegalisib in combination with
About this update from Relay Therapeutics, Inc.
[{"type":"text","content":"Designation supported by robust clinical data from ReDiscover trial with 600mg BID fasted and 400mg BID fed doses of zovegalisib in combination with fulvestrant Initial Phase 1/2 data of zovegalisib + fulvestrant at the 400mg BID fed (Phase 3 dose) in CDK4/6-experienced patients to be presented at ESMO Targeted Anticancer Therapies Congress on March 16 CAMBRIDGE, Mass., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) 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 (HR+/HER2-) locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor. “Approximately 40% of patients with HR+/HER2- advanced breast cancer harbor PIK3CA mutations, and most experience disease recurrence or progression following treatment with CDK4/6 inhibitors, leaving limited therapeutic options,” said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. “This Breakthrough Therapy designation underscores the FDA’s recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date. We look forward to continuing to collaborate closely with the FDA as we work to advance this program as efficiently as possible for patients.” The FDA’s BTD is designed to accelerate the development and review of therapies for serious conditions when early clinical evidence suggests the potential for substantial improvement over available treatments. BTD provides eligibility for all Fast Track designation features, along with enhanced FDA guidance on development and increased engagement with senior FDA leadership. BTD for zovegalisib was supported by clinical data generated to date from the Phase 1/2 ReDiscover trial, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activi...