Core Insights - Novartis received a positive opinion from the CHMP of the EMA for Scemblix (asciminib) to treat adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase across all treatment lines [1][4] Group 1: Treatment Efficacy - Scemblix showed superior major molecular response (MMR) rates compared to all tyrosine kinase inhibitors (TKIs) in the Phase III ASC4FIRST trial, achieving 67.7% MMR at week 48 versus 49.0% for investigator-selected TKIs [2][5] - At week 96, Scemblix maintained superior MMR rates of 74.1% compared to 52% for investigator-selected TKIs [7] - The treatment demonstrated fewer dose reductions and half the rate of adverse events leading to discontinuation compared to existing therapies [2][4] Group 2: Patient Impact - The availability of Scemblix is expected to provide patients with better treatment options, improving their chances of achieving key efficacy milestones while maintaining quality of life [2][3] - Approximately 50% of newly diagnosed CML patients miss treatment goals within one year, highlighting the need for more effective and tolerable treatment options [6] Group 3: Regulatory and Market Position - Scemblix is already approved in over 20 countries, including the US, Japan, and China, and is recommended by the 2025 European LeukemiaNet guidelines for newly diagnosed Ph+ CML-CP patients [3][9] - If approved by the European Commission, Scemblix will expand access to treatment for four times as many patients in Europe [6]