FDA Grants Venetoclax Breakthrough Therapy Designation for Geriatric Patients With Acute Myeloid Leukemia
On July 28, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for venetoclax (Venclexta) in combination with low-dose cytarabine for elderly patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. FDA Breakthrough Therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious or life-threatening diseases and to help ensure that patients receive access to medicines as soon as possible.
Breakthrough Therapy designation was granted based on data from an ongoing open-label phase Ib study of venetoclax in combination with low-dose cytarabine in previously untreated elderly patients (> 65 years) with AML who are ineligible for intensive chemotherapy. Preliminary data from this study was presented by Lin et al at the 22nd European Hematology Association Annual Congress (Abstract E911). Data showed durable efficacy with an acceptable safety profile for venetoclax in combination with low-dose cytarabine in this patient group.
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