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SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) 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
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"- 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. “Receiving our second Rare Pediatric Disease Designation, following pediatric acute lymphoblastic leukemia last month, is another acknowledgment of SLS009’s novel transformational treatment potential to improve the lives of patients, including children with AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. ”This designation reinforces our dedication to addressing the urgent needs of children with AML, including those with treatment-resistant mutations, highlighting the promise of SLS009 to offer the specialized care and support they require, especially considering the limited treatment options for rare pediatric diseases. We look forward to continued SLS009 development and enrolling pediatric AML patients in our Phase 2 clinical trial.” AML prognosis with currently available treatments in the refractory and/or relapsed pediatric patient population remains poor. In a representative study, the 5-year overall survival (OS) rate in relapsed pediatric AML was 33% for all patients, and in patients whose remission lasted less than 12 months only 15.7%. In patients who did not achieve complete remission after one course of chemotherapy 5-year overall survival was 0%. About 50% of children with pediatric AML relapse. General...