Race Oncology receives US FDA rare paediatric disease designation for AML treatment

Proactive - Interviews for investors

Race Oncology Ltd (ASX:RAC) executive director Peter Smith sits down with Proactive’s Meagan Evans to discuss the US Food and Drug Administration’s extension of its Rare Paediatric Disease Designation (RPDD) to RC220 bisantrene for the treatment of childhood (paediatric) subtypes of AML. The RPDD was previously granted to RC110 bisantrene in 2018. This designation is given to new treatments for serious or life-threatening diseases affecting fewer than 200,000 people in the US, primarily those under 18. Some 70% of rare diseases begin in childhood, with 95% lacking approved treatments. The RPDD allows sponsors to qualify for a Priority Review Voucher (PRV) from the US FDA upon marketing approval, enabling a six-month accelerated review of the drug. PRVs can be sold or transferred, with recent sales averaging more than US$100 million. Race Oncology is in discussions with Associate Professor Dr Himalee Sabnis from Emory University and an international paediatric oncology cooperative group to explore trials of RC220 bisantrene as a salvage treatment for paediatric AML. Although no agreements have been finalized, the interest from leading paediatric oncologists is promising. #ProactiveInvestors #RaceOncology #ASX #USFDA #RC220 #bisantrene #RPDD #AML #PriorityReviewVoucher #Biotech #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews