Daurismo Approved to Treat Acute Myeloid Leukemia
November 21, 2018 – The U.S. FDA has approved Daurismo™ (glasdegib), manufactured by Pfizer, for use in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia (AML). Daurismo is indicated to treat adults who are at least 75 years of age or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.
In 2018, an estimated 19,520 individuals in the United States will be diagnosed with AML, while an estimated 10,670 patients will die of the disease. The disease begins in the bone marrow and progresses rapidly, and is the most common type of acute leukemia. Nearly half of patients diagnosed with AML are unable to receive intensive chemotherapy due to comorbidities and chemotherapy-related toxicities.
Patients treated with Daurismo and LDAC in a clinical trial had a median overall survival time of 8.3 months compared to just 4.3 months for patients treated with LDAC alone. Recommended dosing is one 100mg tablet taken by mouth once daily. According to a black box warning, Daurismo can cause embryo-fetal death or severe birth defects when administered to a pregnant woman.
Daurismo will be available in 25mg and 100mg tablets. Pfizer plans to launch the product in December at a wholesale acquisition cost (WAC) of $203,000 per year.