21 November 2018 - The U.S. FDA today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukaemia in adults who are 75 years of age or older or who have other chronic health conditions or diseases (co-morbidities) that may preclude the use of intensive chemotherapy.

The efficacy of Daurismo was studied in a randomised clinical trial in which 111 adult patients with newly diagnosed AML were treated with either Daurismo in combination with low-dose cytarabine (LDAC) or LDAC alone. The trial measured overall survival (OS) from the date of randomisation to death from any cause. Results demonstrated a significant improvement in OS in patients treated with Daurismo. The median OS was 8.3 months for patients treated with Daurismo plus LDAC compared with 4.3 months for patients treated with LDAC only.

The FDA granted this application priority review designation. Daurismo also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Read FDA press release