Melbourne-based Race Oncology has announced its cancer drug Bisantrene has been granted fast-track review by the FDA for the treatment of Acute Myeloid Leukaemia (AML).
The FDA’s designation of childhood AML as a Rare Paediatric Disease (RPD) means Race Oncology can fast-track the review process for approval.
“Race Oncology wants to see this potentially lifesaving drug become available to young children who desperately need options to treat this terrible disease,” said Race CEO Peter Molloy.
Bisantrene (anthracenyl bishydrazone) is an older therapy that has previously been the subject of several phase 2 clinical trials in AML, including childhood AML.
“The data points to the potential value of Bisantrene in treating AML and now our focus is about bringing it to market and saving children suffering from this rare form of leukaemia,” said Mr Molloy.
“In every way, this is a game-changing outcome for Race that adds substantial value to the company.”
The RPD designation was granted in response to a submission from Race.
The company said childhood AML can be considered a substantively different disease to adult AML based on genetic markers disproportionately found in childhood AML and therefore that it constituted a 'rare paediatric disease'.
“Apart from the potential value of the PRV, the FDA designation is important affirmation of the potential clinical value of Bisantrene,” added Mr Molloy.
The company said the next step will be to develop and execute a clinical trial in children with AML to demonstrate the efficacy of Bisantrene.