Novartis’ Scemblix Demonstrates Superior Efficacy and Safety in Newly Diagnosed Leukemia Patients ###

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1. Superior Efficacy: Scemblix demonstrated superior major molecular response (MMR) rates at week 48 compared to standard-of-care tyrosine kinase inhibitors (TKIs) and imatinib alone in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
2. Favorable Safety Profile: Scemblix showed a favorable safety and tolerability profile with fewer adverse events (AEs) and treatment discontinuations compared to both imatinib and second-generation TKIs.
3. Phase III ASC4FIRST Trial: The trial met both primary endpoints with clinically meaningful and statistically significant results, demonstrating Scemblix's potential as a frontline treatment option for newly diagnosed CML patients.
4. ASCO Presentation: The results were presented as a late-breaking abstract at the 2024 American Society of Clinical Oncology (ASCO) meeting.
5. US FDA Breakthrough Therapy Designation: Scemblix received Breakthrough Therapy Designation from the US FDA and is currently under review for approval as a first-line treatment for CML.
6. Commercial Potential: GlobalData expects Scemblix to generate approximately $2.4 billion in sales by 2030.