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Glasdegib: Mechanism, Uses and Side Effects

Glasdegib is an oral anticancer drug used to treat acute myeloid leukemia (AML). It inhibits the Hedgehog signaling pathway and is used in combination with low-dose cytarabine.

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Things worth knowing about "Glasdegib"

Glasdegib is an oral anticancer drug used to treat acute myeloid leukemia (AML). It inhibits the Hedgehog signaling pathway and is used in combination with low-dose cytarabine.

What is Glasdegib?

Glasdegib is a targeted cancer medicine belonging to the class of Hedgehog signaling pathway inhibitors. It is used for the treatment of acute myeloid leukemia (AML) and is available as an oral tablet. Glasdegib has been approved in the European Union and the United States under the brand name Daurismo.

Indication

Glasdegib is approved for the treatment of newly diagnosed AML in adult patients who are not eligible for standard induction chemotherapy. This typically includes elderly patients or those with serious comorbidities who cannot tolerate intensive chemotherapy regimens.

Mechanism of Action

Glasdegib works by inhibiting the protein Smoothened (SMO), a key component of the Hedgehog (Hh) signaling pathway. This pathway plays an important role in cell proliferation and differentiation. In certain cancers, including AML, the Hedgehog pathway is abnormally activated, promoting the survival and proliferation of leukemic stem cells.

By blocking SMO, Glasdegib prevents the transmission of growth signals within cancer cells, slowing or stopping their growth and division.

Dosage and Administration

Glasdegib is used in combination with low-dose cytarabine (LDAC). The standard recommended dose is 100 mg of Glasdegib taken orally once daily, administered in 28-day treatment cycles. The dose may be adjusted based on tolerability and the occurrence of side effects. Glasdegib should be taken at approximately the same time each day.

Side Effects

Like all cancer medications, Glasdegib can cause side effects. Commonly reported adverse effects include:

Hematologic toxicity: Anemia, thrombocytopenia (low platelet count), and neutropenia (low white blood cell count)
Fatigue and weakness
Nausea, vomiting, and diarrhea
Muscle cramps and musculoskeletal pain
QT interval prolongation on ECG (risk of heart rhythm disturbances)
Alopecia (hair loss)
Elevated liver enzyme levels

Patients should be monitored regularly for these side effects. In cases of severe reactions, dose reduction or discontinuation of treatment may be necessary.

Interactions and Precautions

Glasdegib may interact with various other medicines, particularly those that affect the CYP3A4 metabolic pathway. Strong CYP3A4 inhibitors can increase blood levels of Glasdegib, while inducers may reduce its efficacy. In addition, Glasdegib prolongs the QT interval, so concomitant use of other QT-prolonging medicines should be avoided.

Glasdegib must not be taken during pregnancy, as it can cause serious harm to the unborn child. Women of childbearing potential must use reliable contraception during treatment and for a defined period afterward.

Clinical Evidence

The approval of Glasdegib is based on the results of the BRIGHT AML 1003 clinical trial, a randomized Phase II study. This study demonstrated a significantly improved overall survival rate with the combination of Glasdegib and LDAC compared to LDAC alone in patients with newly diagnosed AML who were not eligible for intensive therapy.

References

Cortes JE, et al. - Glasdegib in combination with cytarabine in patients with AML or high-risk MDS: phase 1 study results. American Journal of Hematology, 2018.
European Medicines Agency (EMA) - Daurismo (Glasdegib): European Public Assessment Report, 2020. Available at: www.ema.europa.eu
U.S. Food and Drug Administration (FDA) - Daurismo (glasdegib) Prescribing Information, 2018. Available at: www.fda.gov

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