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FDA Grants Venetoclax Breakthrough Designation for AML Subpopulation

Jason M. Broderick @jasoncology
Published: Friday, Jul 28, 2017

CLL
Venetoclax (Venclexta) has received an FDA breakthrough therapy designation for use in combination with low dose cytarabine (LDAC) in treatment-naïve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie.

Venetoclax is approved by the FDA for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion (del[17p]), following at least 1 prior therapy. The approval was primarily based on data from the phase II M13-982 study, in which venetoclax elicited responses in nearly 80% of patients with relapsed/refractory del(17p) CLL.
Wei AH, Strickland SA, Roboz GJ, et al. Updated safety and efficacy results of phase 1/2 study of venetoclax plus low-dose cytarabine in treatment-naïve acute myeloid leukemia patients aged ≥65 years and unfit for standard induction therapy. Presented at: 2017 EHA Congress; June 22-25, 2017; Madrid, Spain. S473.

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