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FDA grants breakthrough therapy designation to Venclexta for elderly patients with acute myeloid leukemia
The FDA granted breakthrough therapy designation to venetoclax in combination with low-dose cytarabine for elderly patients with previously untreated acute myeloid leukemia, according to the drug’s manufacturer.
The submission to the FDA included data from an ongoing, open-label phase 1b trial designed to evaluate venetoclax (Venclexta; AbbVie, Roche) — a first-in-class BCL2-specific oral inhibitor — in combination with cytarabine for elderly patients with treatment-naive AML who are ineligible for intensive chemotherapy.
Patients treated with the combination regimen demonstrated durable efficacy responses, and the combination’s safety profile appeared acceptable according to a Roche-issued press release.
Researchers presented preliminary data from the study at the European Hematology Association Annual Congress in Madrid.