SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted To SLS009 For The Treatment Of Pediatric Acute Myeloid Leukemia
- Acute Myeloid Leukemia (AML) is the Second Most Common Hematological Malignancy in Children Often Associated with Poorer Prognosis Compared to Other Pediatric Cancers –
- This Recognition Marks SELLAS' Second RPDD Following the Designation for ALL Received Last Month -
- Opened Enrollment for Pediatric AML Patients in Ongoing Phase 2 Clinical Trial -
- RPDD Provides Eligibility for SLS009 to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties –
NEW YORK, July 16, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to SLS009, a highly selective CDK9 inhibitor, for the treatment of pediatric acute myeloid leukemia (AML). The FDA previously granted Orphan Drug and Fast Track Designations to SLS009 for the treatment of AML.