Posted by Michael Wonder on 21 Nov 2018
AbbVie receives US FDA accelerated approval for Venclexta (venetoclax) for treatment of newly-diagnosed acute myeloid leukaemia patients ineligible for intensive chemotherapy
21 November 2018 - The approval in AML is the third provided under priority review by the U.S. FDA for Venclexta, an oral B-cell lymphoma-2 inhibitor, which has been granted four breakthrough therapy designations by the FDA.
AbbVie today announced that the U.S. FDA has granted accelerated approval to Venclexta (venetoclax tablets) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukaemia (AML) in adults who are age 75 years or older, or who have co-morbidities that preclude use of intensive induction chemotherapy.
The FDA accelerated approval is based on two open-label non-randomised trials in patients with newly-diagnosed AML who were age 75 years or older, or had co-morbidities that precluded the use of intensive induction chemotherapy: M14-358, a trial evaluating Venclexta in combination with azacitidine (n=67) or decitabine (n=13), and M14-387, a trial of Venclexta and LDAC (n=61).7 Efficacy was established based on the rate of complete remission (CR) and duration of CR.
