Novartis receives FDA Breakthrough Therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukemia

  • Designation in patients with chronic myeloid leukemia (CML) resistant or intolerant to prior treatments based on positive data from pivotal Phase III ASCEMBL trial evaluating asciminib, an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP)1,2 
  • Despite advances in CML care, many patients are at risk of disease progression, and sequential TKI therapy may be associated with increased resistance and intolerance3-9 
  • Breakthrough …
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