FDA Grants Venetoclax Breakthrough Designation for AML Subpopulation

July 28, 2017 – Venetoclax has received an FDA breakthrough therapy designation for use in combination with low dose cytarabine (LDAC) in treatment-naïve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie. The breakthrough designation, which will expedite the development and review of the combination in this AML subgroup, is the fourth … (leggi tutto)