Glasdegib

(Daurismo®)

Glasdegib

Drug updated on 10/2/2024

Dosage FormTablet (oral; 100 mg, 200 mg)
Drug ClassHedgehog pathway inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • To treat newly-diagnosed acute myeloid leukemia in combination with low-dose cytarabine, in patients ≥ 75 years of age or with comorbidities that preclude use of intensive induction chemotherapy in conjunction with low-dose cytarabine.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • Daurismo (glasdegib) is indicated to treat newly diagnosed acute myeloid leukemia in combination with low-dose cytarabine in patients aged 75 years or older or with comorbidities that preclude the use of intensive induction chemotherapy.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • The addition of targeted therapies (venetoclax or ivosidenib) to hypomethylating agents (HMAs) in patients with acute myeloid leukemia (AML) ineligible for first-line induction chemotherapy resulted in improved survival outcomes, with hazard ratios for overall survival (OS) ranging from 0.44 to 0.66 and event-free survival (EFS) ranging from 0.33 to 0.63.
  • Combination therapies involving HMAs and tyrosine kinase inhibitors (TKIs), with or without venetoclax, in chronic myeloid leukemia at myeloid blastic phase (CML-MBP) patients, demonstrated outcomes that are comparable to intensive chemotherapy combined with TKIs.
  • In older and medically unfit AML patients treated with HMAs or low-dose cytarabine (LDAC), the pooled estimates for complete remission (CR) were 15% (95% CI: 12%-19%), overall response rate (ORR) was 22% (95% CI: 18%-26%), median relapse-free survival (RFS) was 8.8 months (95% CI: 7.7m-10.0m), median overall survival (OS) was 6.3 months (95% CI: 5.3m-7.4m), and 60-day mortality was 21% (95% CI: 18%-25%). The odds of response were 1.85 times higher in patients under 75 years compared to those 75 years and older.
  • Adverse events (AEs) were more frequent with combination therapies compared to control arms, except for the combination of ivosidenib plus azacitidine.
  • There is no safety information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Daurismo (glasdegib) Prescribing Information.2023Pfizer Inc., New York, NY

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines