Drug updated on 10/2/2024
Dosage Form | Tablet (oral; 100 mg, 200 mg) |
Drug Class | Hedgehog 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
Summary
- 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 Title | Year | Source |
---|---|---|
Daurismo (glasdegib) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Therapies for acute myeloid leukemia in patients ineligible for standard induction chemotherapy: a systematic review. | 2023 | Future Oncology |
Management of chronic myeloid leukemia in myeloid blastic phase with novel therapies: a systematic literature review. | 2022 | Expert Review of Hematology |
Efficacy outcomes in the treatment of older or medically unfit patients with acute myeloid leukaemia: a systematic review and meta-analysis. | 2019 | Leukemia Research |