Scemblix FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 2, 2024.
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:
- 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. 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. - Scemblix works by Specifically Targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature).
- 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 musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain, and diarrhea.
Common select laboratory abnormalities include decreased lymphocyte count, decreased leukocyte count, decreased platelet count, decreased neutrophil count, decreased blood calcium corrected levels, increased lipase, increased cholesterol, increased uric acid, increased alanine aminotransferase (ALT), increased alkaline phosphatase (ALP), decreased hemoglobin, increased triglycerides, increased creatine kinase, increased amylase, and increased aspartate aminotransferase (AST).
Development timeline for Scemblix
Further information
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