Shots:
- Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor
- In the cohort, the gedatolisib triplet showed mPFS of 11.1 vs. 5.6mos., & an ORR of 48.9% vs 26% & mDOR of 15.7 vs 7.5mos. Gedatolisib doublet showed mPFS of 11.3 vs. 5.6mos., with an ORR of 35.7% & mDOR of 24.2mos.; early OS data showed promising trends for both combinations; data presented at ASCO’26
- Celcuity plans to submit VIKTORIA-1 data to the FDA as an sNDA & to other authorities thereafter. Separately, the FDA is reviewing its NDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer (PDUFA: Jul 17, 2026)
Ref: Globenewswire| Image: Celcuity | Press Release
Related News: The US FDA Accepts Celcuity’s Gedatolisib NDA under Priority Review to Treat HR+/HER2- Breast Cancer
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