Pfizer’s Daurismo (glasdegib) Receives FDA Approval for Adults with Newly-Diagnosed Acute Myeloid Leukemia (AML)

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• The approval is based on P-II BRIGHT (1003) trial study results assessing Daurismo + cytarabine (LDAC) & daunorubicin vs PBO + cytarabine & daunorubicin in 115 patients in ratio (2:1) with newly diagnosed AML
• The P-II BRIGHT (1003) study resulted in median OS 8.3 mos and 54% reduction in the risk of death for patients
• Daurismo (glasdegib) is an oral qd Hedgehog pathway inhibitor indicated for the treatment of patients with newly diagnosed AML in adult patients who are >75 years

Click here to read full press release/ article | Ref: Pfizer | Image: Twitter