23 April 2021 - Positive opinion based on data from the VIALE-A and M14-358 trials, which evaluated the safety, efficacy and pharmacokinetics of Venclyxto in combination with hypomethylating agents in adult patients with acute myeloid leukaemia.
AbbVie today announced that the CHMP of the EMA adopted a positive opinion for Venclyxto (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy.