Aprea Therapeutics, Inc., a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumour suppressor protein, p53, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eprenetapopt in the treatment of patients with TP53 mutant acute myeloid leukaemia (AML). The Company previously received Breakthrough Therapy, Orphan Drug and Fast Track designations for eprenetapopt in the treatment of patients with TP53 mutant myelodysplastic syndromes (MDS).
The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the drug candidate’s development plan as well as eligibility for accelerated approval and priority review.
“We are pleased to have received Fast Track designation for eprenetapopt in the treatment of TP53 mutant AML, cancer for which outcomes are poor and there are no current therapeutic options specifically for these patients,” said Eyal C. Attar, M.D., Chief Medical Officer of Aprea. “Emerging data from our AML trials evaluating eprenetapopt with azacitidine, and with eprenetapopt, azacitidine and venetoclax, are promising and we continue to enrol patients to identify the best treatment regimen. As these data mature in 2021, we look forward to continued interaction with FDA as we map out opportunities for an accelerated pathway to potential approval.”