Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer
Celcuity submitted a supplemental New Drug Application to the FDA for REVTORPYK for the treatment of HR+/HER2- advanced breast cancer with a PIK3CA mutation. The submission is supported by Phase 3 VIKTORIA-1 data where the REVTORPYK triplet regimen reduced the risk of disease progression or death by 50% versus the control arm, achieving a median PFS of 11.1 months compared to 5.6 months.
Key figures
- Drug Name
- REVTORPYK (gedatolisib)
- Phase Of Trial
- Phase 3
- Orr doublet percent
- 36
- Orr triplet percent
- 49
- Hazard ratio doublet
- 0.51
- Hazard ratio triplet
- 0.5
- Subjects mutant cohort
- 350
- Median dor doublet months
- 24.2
- Median dor triplet months
- 15.7
- Median pfs control months
- 5.6
- Median pfs doublet months
- 11.3
- Median pfs triplet months
- 11.1
AI analysis
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