European Commission approval for Venclyxto + a hypomethylating agent for newly diagnosed acute myeloid leukemia – AbbVie

AbbVie announced 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. 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. 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.

This most recent approval is based on results from the Phase III 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). 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.

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. 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.

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.