Mali Barbi, Medical Oncologist at Northwell Health, shared a post on X:
“Breaking: FDA accepts Celcuity’s NDA for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer!
We finally have a path for the 60% of patients without mutations. In VIKTORIA-1, the gedatolisib triplet slashed the risk of progression by 76% (mPFS 9.3m vs 2.0m).
The biological difference? It’s a dual PI3K/mTORC1/2 pan-inhibitor. By shutting down the mTORC2 feedback loop that typically reactivates Akt, we are closing the door on the tumor’s favorite escape route.
Hurvitz SA, et al. Gedatolisib plus fulvestrant, with & without palbociclib, vs fulvestrant in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer: first results from VIKTORIA-1.
Presented at: 2025 ESMO Annual Congress. Abstract LBA17.”
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