FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves Two AML Treatments

Dec. 3, 2018

The FDA approved Pfizer’s Daurismo (glasdegib) tablets for use in combination with low-dose cytarabine (LDAC) chemotherapy for the treatment of newly-diagnosed acute myeloid leukemia in adults who are 75 years of age or older or who have other chronic conditions or diseases that preclude the use of intensive chemotherapy.

The approval was based on results from a clinical trial in which 111 adult patients treated with either Daurismo in combination with LDAC or LDAC alone. The median overall survival rate was 8.3 months for patients treated with Daurismo plus LDAC compared with 4.3 months for patients treated with just LDAC.

The agency granted Daurismo a priority review and an orphan drug designation.

The FDA also approved AbbVie’s Venclexta (venetoclax) in combination with azacitidine, decitabine or low-dose cytarabine for treating patients with acute myeloid leukemia aged 75 or older, as well as those who cannot receive intensive chemo.

The FDA previously approved Venclexta for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least one prior therapy.

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