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On June 30, 2020, the European Commission approved glasdegib, an oral smoothened inhibitor, in combination with low-dose cytarabine (LDAC) for the treatment of newly diagnosed de novo or secondary acute myeloid leukemia (AML) in patients ineligible for standard chemotherapy. This approval follows the positive opinion received from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use and the approval by the U.S. Food and Drug Administration (FDA). The European Commission’s approval was based on the results from the phase II BRIGHT 1003 trial (NCT01546038).1 Follow-up data and 4-year overall survival from this trial were recently presented as an e-poster at the 25th European Hematology Association Annual Congress.
Table 1. Most frequently reported hematological and non-hematological adverse events in patients receiving glasdegib
Adverse event |
% of patients (n = 78) |
---|---|
Hematological |
|
Anemia |
45.2 |
Hemorrhages |
45.2 |
Febrile neutropenia |
35.7 |
Thrombocytopenia |
30.9 |
Non-hematological |
|
Nausea |
35.7 |
Decreased appetite |
33.3 |
Fatigue |
30.9 |
Muscle spasms |
30.9 |
Pyrexia |
29.7 |
Diarrhea |
28.5 |
Pneumonia |
28.5 |
Dysgeusia |
26.1 |
Peripheral edema |
26.1 |
Constipation |
25.0 |
Abdominal pain |
25.0 |
Rash |
25.0 |
Dyspnea |
25.0 |
Vomiting |
21.4 |
Decreased weight |
20.2 |
Glasdegib is currently being assessed in the phase III BRIGHT AML1019 trial (NCT03416179) in combination with intensive chemotherapy or in combination with azacitidine in patients with previously untreated AML.4
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