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These highlights do not include all the information needed to use SCEMBLIX safely and effectively. See full prescribing information for SCEMBLIX. SCEMBLIX® (asciminib) tablets, for oral use Initial U.S. Approval: 2021
Medication labelWhy this: Advisory · dailymed-prescription
SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation.
- generic_name
- asciminib
- product_names
- asciminib
- ndc
- 0078-1091, 0078-1091-20, 0078-1091-94, 0078-1098, 0078-1098-20, 0078-1098-05, 0078-1098-30, 0078-1098-94, 0078-1196, 0078-1196-20
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en