Complete Story
New indication for VENCLEXTA® (venetoclax tablets)
On November 21, 2018, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
VENCLEXTA is also approved for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
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