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NOV 20 2026
UPCOMING · 170 DAYS TO PDUFA

Celcuity gedatolisib $CELC

for HR+/HER2-/PIK3CA wild-type advanced or metastatic breast cancer

NDA · Standard Review

Accepted JAN 20 2026.

About

HR+/HER2- breast cancer grows when hormone receptors and growth signals overactivate the PI3K/mTOR pathway, driving uncontrolled cell division. Gedatolisib blocks both PI3K and mTOR proteins simultaneously, shutting down this growth pathway at multiple points. By targeting these key signaling hubs, the drug may slow tumor progression in cancers that lack PIK3CA mutations but still rely on the pathway.

Pivotal trial

VIKTORIA-1 Phase 3 active not recruiting NCT05501886

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Source: ClinicalTrials.gov

Also in development