Shots:
- The US FDA has accepted NDA under priority review of gedatolisib in HR+/ HER2-, PIK3CA wild-type advanced breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jul 17, 2026)
- NDA was supported by data from the PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts
- Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor that potently blocks all Class I PI3K isoforms & mTORC1/2 for comprehensive PAM pathway inhibition, & has received both BTD & FTD based on early clinical data
Ref: Globenewswire | Image: Celcuity | Press Release
Related News: The US FDA Receives Celcuity’s NDA for Gedatolisib to Treat Advanced Breast Cancer
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
