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# Partial Hold Lifted on Ewing Sarcoma Drug
- URL: https://www.fdaweb.com/partial-hold-lifted-on-ewing-sarcoma-drug/
- Published: 2023-05-09T12:00:00.000Z
- Updated: 2026-09-14T18:30:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154407

FDA has removed a partial clinical hold against Salarius Pharmaceuticals and its Phase 1/2 clinical trial evaluating seclidemstat in patients with Ewing sarcoma, a rare and deadly pediatric bone cancer. Salarius says the hold was lifted following the submission of “safety and clinical information to assure the FDA of seclidemstat’s compelling risk-benefit profile.” The agency previously granted fast track, orphan drug and rare pediatric disease designations for the reversible, targeted LSD1 inhibitor, according to the company.

The Phase 1/2 trial is now in its dose-expansion stage with one arm designed to enroll up to 30 patients with Ewing sarcoma that will investigate seclidemstat in combination with topotecan and cyclophosphamide, a commonly used second- and third-line chemotherapy regimen, the company says.