Immunome Announces U.S. FDA Acceptance of New Drug Application for Varegacestat for the Treatment of Adults with Desmoid Tumors
Immunome announced that the FDA has accepted the New Drug Application for varegacestat for the treatment of desmoid tumors, setting a PDUFA target action date of April 28, 2027. The submission is supported by Phase 3 RINGSIDE trial data demonstrating an 84% reduction in the risk of disease progression or death compared to placebo, with an objective response rate of 56%.
Key figures
- Drug Name
- Varegacestat
- Phase Of Trial
- Phase 3
- Ae rash
- 43%
- P value
- <0.0001
- Ae cough
- 34%
- Ae nausea
- 35%
- Ae fatigue
- 44%
- Pdufa date
- April 28, 2027
- Ae diarrhea
- 82%
- Hazard ratio
- 0.16
- Grade 1 or 2 events
- 95%
- Total patients randomized
- 156
- Objective response rate placebo
- 9%
- Median tumor volume change placebo
- +11%
- Objective response rate varegacestat
- 56%
- Median tumor volume change varegacestat
- -83%
AI analysis
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