What is the role of glasdegib in the treatment of acute myeloid leukemia (AML)?

Updated: May 26, 2020
  • Author: Karen Seiter, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

In 2018, the FDA approved glasdegib, a hedgehog pathway inhibitor, for newly diagnosed AML. It is indicated in adults aged 75 years or older, or adults who have comorbidities that preclude use of intensive induction chemotherapy in combination with low-dose cytarabine. Approval was based on interim results of the phase 2 BRIGHT 1003 study that evaluated glasdegib combined with low-dose cytarabine (LDAC) or LDAC alone. Median OS was 8.8 months for patients treated with glasdegib plus LDAC compared with 4.9 months for LDAC. This difference represented a nearly 50% reduction in the risk of death for patients treated with glasdegib plus cytarabine. [59]  

Final outcome of the BRIGHT 1003 study confirmed that glasdegib LDAC significantly improved OS vs LDAC alone (hazard ratio, 0.495 [95% CI, 0.325-0.752]; P=0.0004). Furthermore, the addition of glasdegib to LDAC did not result in a substantial increase in adverse events. [60]


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