Posted by Michael Wonder on 17 Oct 2020
Venclexta (venetoclax) receives FDA full approval for acute myeloid leukaemia
16 October 2020 - The FDA approval of Venclexta for newly diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from a series of trials including two Phase 3 trials - VIALE-A (M15-656) and VIALE-C (M16-043).
AbbVie today announced that the U.S. FDA has provided full approval to Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
The FDA previously granted accelerated approval to Venclexta for this indication in 2018.
