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Salarius Pharma gets US FDA fast-track tag for drug to treat rare bone cancer

Salarius Pharmaceuticals Inc.'s drug to treat a rare bone cancer called seclidemstat has received the U.S. Food and Drug Administration's fast-track designation.

Fast-track designation means Houston-based Salarius will communicate more frequently with the FDA and receive an expedited development and review process for seclidemstat.

The drug is intended to treat Ewing sarcoma, most common in children and young adults, that has returned or is resistant to standard-of-care therapy, according to Salarius' Dec. 16 press release. Seclidemstat, which blocks the overexpressed LSD1 enzyme, previously received orphan-drug and rare pediatric disease designations from the FDA.

No targeted therapies are approved to treat Ewing sarcoma, Salarius said.

Seclidemstat is now in a phase 1/2 clinical trial for the disease and is also being tested in advanced solid tumors such as prostate, breast and ovarian cancers.