Novartis Receives FDA Approval for Scemblix as First-Line Treatment for CML

Novartis today announced that the FDA has approved Scemblix (asciminib) for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). In the Phase 3 ASC4FIRST trial, Scemblix demonstrated a statistically significant improvement in major molecular response rate at week 48 compared to standard-of-care TKIs. This approval makes Scemblix the first STAMP inhibitor approved as a first-line treatment for CML, offering a differentiated mechanism of action compared to existing TKIs.