Celcuity completes NDA submission to FDA for gedatolisib in HR+/HER2- advanced breast cancer under RTOR program

Celcuity Inc.

NDA submitted for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer.
Submitted under FDA's RTOR program; drug previously received Breakthrough Therapy and Fast Track designations.
Phase 3 VIKTORIA-1: triplet reduced risk of progression/death by 76% (HR 0.24); median PFS 9.3 mo vs 2.0 mo.
Doublet (gedatolisib + fulvestrant) reduced risk by 67% (HR 0.33); median PFS 7.4 mo vs 2.0 mo.
CEO Sullivan: 'unprecedented efficacy results and overall safety profile are potentially practice changing.'

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