— VENCLYXTO® (venetoclax) in combination with a hypomethylating agent is a new regimen approved by the European Commission (EC) for patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy 
— Approval is based on data from AbbVie’s clinical trial program for VENCLYXTO, including the Phase 3 VIALE-A trial, which showed patients treated with VENCLYXTO in combination with azacitidine demonstrated improvements in overall survival versus patients treated with placebo in combination with azacitidine 
— Approval is also based on results of the Phase 1b M14-358 trial which showed patients treated with VENCLYXTO in combination with azacitidine or decitabine achieved high remission rates 
NORTH CHICAGO, Ill., May 25, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) announced today that the European Commission (EC) has approved VENCLYXTO® (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.1 The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway.
“VENCLYXTO has proven incremental overall survival in treating newly diagnosed AML in patients who are ineligible for intensive chemotherapy when treated with VENCLYXTO plus azacitidine compared to those treated with azacitidine alone,” said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. “We look forward to bringing VENCLYXTO to more AML patients who can potentially benefit from this important new treatment option in EU countries.”
This is the third extension of indications for VENCLYXTO, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells.1
This most recent approval is based on results from the Phase 3 double-blind, placebo-controlled VIALE-A (M15-656) and the Phase 1b open-label, nonrandomized, multicenter M14-358 clinical trials. The VIALE-A trial demonstrated patients who received VENCLYXTO in combination with azacitidine showed statistically significantly greater median overall survival (OS) than patients receiving azacitidine alone (p<0.001).2 The Phase 1b M14-358 trial evaluating venetoclax in combination with hypomethylating agents, azacitidine or decitabine, exhibited an overall safety profile that was generally consistent with the known safety profiles of venetoclax combined with azacitidine and the two medications alone.3
In the VIALE-A trial, the most frequently reported serious adverse events (AEs) in the VENCLYXTO plus azacitidine arm and placebo plus azacitidine arm were febrile neutropenia, pneumonia, sepsis, and haemorrhage.2 In the M14-358 trial, the most frequently reported serious AEs in patients receiving VENCLYXTO in combination with decitabine were febrile neutropenia, pneumonia, bacteraemia and sepsis.3
“The European Commission approval of venetoclax combination therapy offers a new option for people facing what is often a devastating acute myeloid leukemia diagnosis,” said Zack Pemberton-Whiteley, Chair of the Acute Leukemia Advocates Network. “This approval represents an important advancement for the treatment of AML and offers an option for those who are ineligible for intensive chemotherapy.”
In April 2021, AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for the Marketing Authorization Application for VENCLYXTO in combination with hypomethylating agents for the treatment of patients with newly diagnosed AML who are ineligible for intensive chemotherapy.
VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.