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FDA Approval Sought for Frontline Venetoclax Combo in AML

Jason M. Broderick @jasoncology
Published: Thursday, Jul 12, 2018

Dr. Sandra Horning

Sandra Horning, MD
A supplemental New Drug Application (sNDA) has been submitted to the FDA for venetoclax (Venclexta) for use in combination with a hypomethylating agent or low-dose cytarabine (LDAC) for the first-line treatment of patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to AbbVie and Genentech, the codevelopers of the BCL-2 inhibitor.

The overall response rate was 92% versus 72%, respectively.


  1. Genentech Announces Submission of Supplemental New Drug Application for Venclexta for People With Previously Untreated Acute Myeloid Leukemia who are Ineligible for Intensive Chemotherapy. Published July 12, 2018. Accessed July 12, 2018.
  2. Seymour JF, Kippes TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia [published online March 22, 2018]. N Engl J Med. 2018; 378:1107-1120. doi: 10.1056/NEJMoa1713976.

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