OS Therapies wins FDA Type C meeting to review 2.5-year survival data for OST-HER2 Phase 2b osteosarcoma trial
OSTX•FDA meeting secured for OST-HER2 survival data review
OS Therapies secured an FDA Type C statistical methods meeting to review 2.5-year survival data from its OST-HER2 Phase 2b osteosarcoma trial.
Results have already been observed through 2.5 years, showing the earlier survival benefit held up over time without deterioration.
Interim 3-year overall survival results are expected in early September 2026, ahead of the FDA meeting scheduled for mid-September 2026.
Regulatory strategy hinges on the meeting’s outcome, including the comparator approach for efficacy interpretation and potential RMAT designation.
Decisions on an FDA rolling review path and timing for a potential accelerated-approval BLA are expected to follow, targeting year-end 2026.
