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
- The trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while the 2EP, outside the primary hierarchical analysis, also showed improved PFS with gedatolisib + fulvestrant; data to be presented at ASCO’26
- Celcuity plans to submit this data as an sNDA to the US FDA & other regulators, while the FDA has granted Priority Review for gedatolisib in HR+/HER2- PIK3CA-wild type advanced breast cancer with a PDUFA date of 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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