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Daurismo FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 27, 2018.

FDA Approved: Yes (First approved November 21, 2018)
Brand name: Daurismo
Generic name: glasdegib
Dosage form: Tablets
Company: Pfizer Inc.
Treatment for: Acute Myeloid Leukemia

Daurismo (glasdegib) is a hedgehog pathway inhibitor indicated for the combination treatment of adult patients ≥75 years with newly-diagnosed acute myeloid leukemia (AML).

  • Daurismo (glasdegib) works by binding to and inhibiting Smoothened (Smo), a transmembrane protein involved in hedgehog signal transduction. Studies have shown that disruption of the Hedgehog signaling pathway pathway can impair the development and survival of cancer stem cells.
  • In the Phase 2 BRIGHT 1003 trial, 115 patients with newly diagnosed AML were randomized 2:1 to receive Daurismo plus low-dose cytarabine (LDAC) or LDAC alone. Median overall survival was 8.3 months for patients treated with Daurismo plus LDAC, compared with 4.3 months for patients treated with LDAC alone. This difference represented a 54 percent reduction in the risk of death for patients treated with Daurismo plus LDAC.
  • Daurismo is taken orally, once daily, in combination with low-dose cytarabine.
  • The labeling for Daurismo includes a boxed warning for embryo-fetal toxicity. The most common side effects (incidence ≥20%) reported during clinical trials were anemia, fatigue, hemorrhage, febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite, dysgeusia, mucositis, constipation, and rash.

Development timeline for Daurismo

Nov 21, 2018Approval FDA Approves Daurismo (glasdegib) for Patients with Acute Myeloid Leukemia
Jun 27, 2018FDA Grants Priority Review for Pfizer’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia

Further information

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