Posted by Michael Wonder on 12 Jul 2018
AbbVie announces submission of supplemental new drug application to US FDA for venetoclax in newly diagnosed acute myeloid leukaemia patients ineligible for intensive chemotherapy
12 July 2018 - The US FDA has granted venetoclax two breakthrough therapy designations in acute myeloid leukaemia, which are designed to expedite the development and review of medicines that are intended to treat a serious condition.
AbbVie today announced it submitted a supplemental new drug application to the U.S. FDA for venetoclax in combination with a hypomethylating agent (HMA) or in combination with low-dose cytarabine (LDAC) for the treatment of newly diagnosed patients with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
The sNDA submission is based on investigational data from two studies: M14-358, a Phase 1b trial evaluating venetoclax in combination with an HMA (azacitidine or decitabine), and M14-387, a Phase 1/2 trial of venetoclax in combination with LDAC.
