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# Rare Pediatric Disease Status for Leukemia Drug
- URL: https://www.fdaweb.com/rare-pediatric-disease-status-for-leukemia-drug/
- Published: 2024-07-16T12:00:00.000Z
- Updated: 2026-09-14T14:35:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157356

FDA has granted Sellas Life Sciences Group a Rare Pediatric Disease Designation (RPDD) for SLS009, a highly selective CDK9 inhibitor for treating pediatric acute myeloid leukemia (AML). Previously, the agency granted Orphan Drug and Fast Track Designations for the therapy. The company says it is continuing enrollment in a pediatric AML Phase 2 clinical trial.

An RPDD could entitle the company to a priority review voucher (PRV) if an NDA for SLS009 is submitted and approved. “PRVs may be used by the sponsor or sold to another sponsor for their use and have recently sold for approximately $100 million,” Sellas says.