Posted by Michael Wonder on 28 May 2021
Novartis receives FDA fast track designation for sabatolimab (MBG453) in myelodysplastic syndromes
25 May 2021 - Novartis today announced that the US FDA has granted fast track designation for sabatolimab (MBG453) for the treatment of adult patients with myelodysplastic syndromes defined with an IPSS-R risk category of high or very high risk in combination with hypomethylating agents.
The STIMULUS clinical trial program includes multiple studies evaluating sabatolimab as part of different combination therapies in patients with myelodysplastic syndromes and acute myeloid leukaemia.
