Posted by Michael Wonder on 25 Apr 2024
Deverra Therapeutics granted FDA fast track designation for DVX101 (dilanubicel) for the treatment of acute myeloid leukaemia
24 April 2024 - Deverra Therapeutics today announced that the US FDA granted fast track designation to dilanubicel, the Company's lead candidate for the treatment of newly diagnosed acute myeloid leukaemia to improve response with first-line therapy.
Dilanubicel was recently granted orphan drug designation and Regenerative Medicine Advanced Therapy designation and has now also been granted fast track designation based on the potential of DVX101 (dilanubicel) to address the significant unmet medical need in the treatment of patients with newly diagnosed AML, where the 5 year overall survival rate remains less than 30%.
