The US Food and Drug Administration (FDA) has awarded Priority Review Designation to glasdegib, an experimental drug designed as a treatment for previously untreated acute myeloid leukaemia in combination with a form of chemotherapy called low-dose cytarabine. Glasdegib is not currently approved by any regulator, but the FDA has received a New Drug Application from Pfizer. The original article can be read here, on Pfizer’s website.
Acute Myeloid Leukaemia
Leukaemia is cancer that affects white blood cells, and it is known as myeloid leukaemia when it is cancer of the myeloid cells. Myeloid cells are involved in various functions, including stopping tissue damage spreading, and protecting the body from bacterial infections and parasites. Myeloid leukaemia is acute when it progresses rapidly and is likely to need immediate treatment.
According to Pfizer’s article, acute myeloid leukaemia (AML) accounts for an estimated 80% of all acute leukaemia cases. This year, it is predicted that 19,520 people will be diagnosed with the condition in the US. However, this cancer is associated with high mortality rates, and new treatment options are needed for patients.
About Glasdegib
Glasdegib, Pfizer’s investigational drug being developed for the treatment of adults with previously untreated AML, is designed to inhibit the SMO receptor to disrupt the “Hedgehog” pathway. Alteration of this pathway has been linked to several types of cancer.
Glasdegib has just been given Priority Review by the FDA, which means that they will aim to respond to an application within six months rather than the standard ten. Pfizer has also submitted a New Drug Application on behalf of glasdegib.
Research into Glasdegib
A recently completed Phase 2 clinical trial (Bright 1003) of glasdegib in combination with low-dose cytarabine (LDAC) found that patients who took the combination therapy showed improved survival compared to those who only received LDAC. The study was an open-label, randomised trial involving 132 patients who had high-risk myelodysplastic syndrome or AML. The median survival was 4.9 months for patients given LDAC alone, and 8.8 months for those taking the combination therapy.
A Phase 3 trial (Bright AML 1019) will look at the effects of adding glasdegib to intensive or non-intensive chemotherapy for patients who are recently diagnosed with AML. The study began enrolling patients earlier this year.
