Posted by Michael Wonder on 10 May 2024
Novartis receives FDA breakthrough therapy designation for Scemblix in first-line CML
10 May 2024 - Breakthrough therapy designation was granted based on positive data from the Phase 3 ASC4FIRST study, in which Scemblix met both primary endpoints with superior MMR rates at week 48 compared to investigator-selected tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib and bosutinib) and compared to imatinib alone.
Novartis announced that the FDA has granted breakthrough therapy designation to Scemblix (asciminib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase. This marks the third breakthrough therapy designation for Scemblix.
