Celcuity's Gedatolisib Achieves Phase 3 Success in PIK3CA-Mutant Breast Cancer as FDA Decision on Wild-Type NDA Nears

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Celcuity announced positive topline Phase 3 results from the PIK3CA-mutant cohort of the VIKTORIA-1 trial in HR+/HER2- advanced breast cancer, meeting the primary endpoint of progression-free survival (PFS) improvement with gedatolisib plus fulvestrant (with or without palbociclib) versus alpelisib plus fulvestrant.235

Gedatolisib regimens showed statistically significant and clinically meaningful PFS benefits and were generally well tolerated with no new safety signals.235

The FDA accepted Celcuity's NDA for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer, granting priority review with a PDUFA goal date of July 17, 2026.14

VIKTORIA-1 data from both PIK3CA-mutant and wild-type cohorts support gedatolisib's potential to improve second-line treatment regardless of PIK3CA status.35

HR+/HER2- breast cancer is the most common subtype (about 70% of cases), with ~40% having PIK3CA mutations.5

Sources:

1. https://www.cancernetwork.com/view/fda-accepts-nda-for-gedatolisib-in-hr-her2-pik3ca-wild-type-breast-cancer

2. https://www.stocktitan.net/sec-filings/CELC/8-k-celcuity-inc-reports-material-event-a18ca0c4ce46.html

3. https://markets.businessinsider.com/news/stocks/celcuity-s-phase-3-viktoria-1-trial-achieves-primary-endpoint-with-clinically-meaningful-improvement-in-progression-free-survival-in-pik3ca-mutant-cohort-1036096970

4. https://www.managedhealthcareexecutive.com/view/fda-accepts-nda-for-gedatolisib-celcuity-s-investigational-breast-cancer-treatment

5. https://www.stocktitan.net/news/CELC/celcuity-s-phase-3-viktoria-1-trial-achieves-primary-endpoint-with-m8yxb6qj5hj9.html