CHMP recommends Daurismo intended for the treatment of acute myeloid leukaemia .- Pfizer

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Daurismo intended for the treatment of acute myeloid leukaemia (AML). The applicant for this medicinal product is Pfizer Europe MA EEIG. Daurismo will be available as 25 mg and 100 mg film-coated tablets.

The active substance of Daurismo is glasdegib, an antineoplastic agent (ATC code: L01XX63). Glasdegib is an inhibitor of the Hedgehog (Hh) signal transduction pathway. It binds to a transmembrane protein (Smoothened, SMO), leading to decreased glioma-associated oncogene (GLI) transcription factor activity and downstream pathway signalling, thus reducing GLI1 levels in AML cells and the leukaemic initiating potential of AML cells.

The benefits of Daurismo are its ability to improve the overall survival when combined with low-dose cytarabine. The most common side effects are nausea, decreased appetite, fatigue, muscle spasms, diarrhoea, dysgeusia, constipation, abdominal pain, rash and vomiting. The most frequent severe adverse reaction reported was fatigue.