NEWS
SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia
SELLAS Life Sciences has received Rare Pediatric Disease Designation (RPDD) from the FDA for its drug SLS009, targeting pediatric acute lymphoblastic leukemia (ALL), the most prevalent cancer among children.
This designation makes SLS009 eligible for a Priority Review Voucher (PRV) upon marketing approval, which can be sold, historically fetching around $100 million.
SLS009 is a selective CDK9 inhibitor that has shown a favorable safety profile in clinical trials, with no high-grade non-hematologic toxicities.
The RPDD recognizes the critical need for new treatments in pediatric ALL, where relapse rates remain high, particularly in high-risk groups.
SELLAS aims to expedite the clinical development of SLS009, offering potential new treatment options for children with ALL and improving their long-term event-free survival (EFS).
This designation makes SLS009 eligible for a Priority Review Voucher (PRV) upon marketing approval, which can be sold, historically fetching around $100 million.
SLS009 is a selective CDK9 inhibitor that has shown a favorable safety profile in clinical trials, with no high-grade non-hematologic toxicities.
The RPDD recognizes the critical need for new treatments in pediatric ALL, where relapse rates remain high, particularly in high-risk groups.
SELLAS aims to expedite the clinical development of SLS009, offering potential new treatment options for children with ALL and improving their long-term event-free survival (EFS).
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