Novartis' Scemblix Outperforms Standard Treatments in Phase III Leukemia Trial
TL;DR
Novartis' Phase III ASC4FIRST trial shows that Scemblix® (asciminib) is more effective and has a better safety profile than standard-of-care tyrosine kinase inhibitors (TKIs) in treating newly diagnosed chronic myeloid leukemia (CML). Scemblix achieved higher major molecular response rates at week 48 compared to other TKIs and imatinib alone, with fewer adverse events and treatment discontinuations. The trial results have been submitted to the FDA for review, and Scemblix has been granted Breakthrough Therapy Designation.
- Novartis Scemblix® Phase III data first to show superior efficacy with a favorable safety and tolerability profile vs. standard-of-care TKIs in adults with newly diagnosed CML Novartis
- ASCO24: Novartis Leukemia Drug Beats Older Drugs in Phase III Readout BioSpace
- ASCO: Novartis' Scemblix proves edge over predecessor Gleevec in newly diagnosed leukemia FiercePharma
- Novartis CEO: Our leukemia drug Scemblix is a potential $3 billion plus medicine CNBC
- STAMP Inhibitor Tops Imatinib, Second-Gen TKIs for Newly Diagnosed CML Medpage Today
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