FDA Grants Accelerated Approval to Novartis’ Scemblix for Newly Diagnosed Chromosome-Positive Chronic Myeloid Leukemia

Accelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix’s superior efficacy in achieving major molecular response compared to standard of care tyrosine kinase inhibitors in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.