Race Oncology Ltd (ASX:RAC, OTC:RAONF) CEO Daniel Tillett sits down with Proactive's Jonathan Jackson after the US Food and Drug Administration (FDA) extended Orphan Drug Designation (ODD) to its proprietary formulation of bisantrene, RC220. Initially, the ODD was granted to Update Pharma Inc. in 2014 for the RC110 formulation of bisantrene for the treatment of acute myeloid leukemia (AML). The designation was transferred to Race in 2017 and has been maintained through annual reporting of clinical and non-clinical activities to the FDA. The ODD program, established under the Orphan Drug Act of 1983, aims to promote the development of treatments for rare diseases affecting fewer than 200,000 people in the USA. Benefits include seven-year US marketing exclusivity, a 25% federal tax credit for clinical research expenses, waiver of Prescription Drug User Fee Act (PDUFA) fees (valued at US$4 million in 2024) and eligibility for research grants and additional regulatory guidance from the FDA. Tillett, expressed gratitude for the clinical team's efforts in securing the ODD extension for RC220 bisantrene. Chief medical officer Dr Michelle Rashford notes that the designation enables closer collaboration with the FDA on all RC220 bisantrene clinical programs as Race progresses towards opening an FDA Investigational New Drug (IND) application in 2025.
Race Oncology receives FDA orphan drug designation extension for bisantrene RC220
