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Scemblix FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 30, 2021.

FDA Approved: Yes (First approved October 29, 2021)
Brand name: Scemblix
Generic name: asciminib
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: Chronic Myelogenous Leukemia

Scemblix (asciminib) is a tyrosine kinase inhibitor used for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

  • Scemblix is indicated for the treatment of adult patients with:
    • Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). This indication is approved under accelerated approval based on major molecular response (MMR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    • Ph+ CML in CP with the T315I mutation.
  • Scemblix works by Specifically Targeting the ABL Myristoyl Pocket (STAMP). It is the first-in-class STAMP inhibitor and provides an important development in addressing tyrosine-kinase inhibitor (TKI)-resistance for patients with CML who suffer intolerance or inadequate response after at least two previous TKI treatments.
  • Scemblix tablets are taken orally once or twice daily without food.
  • Scemblix may cause serious adverse reactions including myelosuppression, pancreatic toxicity, hypertension, hypersensitivity reactions, and cardiovascular toxicity.
  • Common adverse reactions include upper respiratory tract infections, musculoskeletal pain, fatigue, nausea, rash, diarrhea, and laboratory abnormalities.

Development timeline for Scemblix

DateArticle
Oct 29, 2021Approval FDA Approves Scemblix (asciminib) for the Treatment of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia (Ph+ CML)
Dec  8, 2020Novartis Investigational STAMP Inhibitor Asciminib (ABL001) Shows Superior MMR Rate to Bosulif┬«* in Chronic Myeloid Leukemia Trial

Further information

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