The Food and Drug Administration (FDA) has granted full approval to Venclexta® (venetoclax; AbbVie) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. Previously, the treatment was granted accelerated approval for this indication.

The full approval was based on efficacy and safety data from the phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies in adults with newly diagnosed AML, along with updated data from the phase 1b M14-358 and the phase 1/2 M14-387 studies.

Results from VIALE-A showed that treatment with venetoclax plus azacitidine was associated with a 34% reduction in the risk of death compared with placebo plus azacitidine (hazard ratio [HR] 0.66; 95% CI, 0.52-0.85; P <.001); median OS was 14.7 months (95% CI, 11.9-18.7) in the venetoclax arm vs 9.6 months (95% CI, 7.4-12.7) in the placebo arm. Additionally, significantly more patients in the venetoclax group achieved complete remission (CR) compared with those who received azacitidine alone (37% [95% CI, 31-43] vs 18% [95% CI, 12-25], respectively; P <.001).

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In VIALE-C, venetoclax plus LDAC did not significantly improve OS compared with placebo plus LDAC (HR 0.75; 95% CI, 0.52-1.07; P =.114); median OS was 7.2 months (95% CI, 5.6-10.1) vs 4.1 months (95% CI, 3.1-8.8), respectively. Complete remission (CR) was observed in 27% (95% CI, 20-35) of the venetoclax arm compared with 7.4% (95% CI, 2.4-16) for placebo. Additionally, the CR+CRh (complete remission with partial hematological recovery) rate was 47% (95% CI, 39-55) for venetoclax vs 15% for placebo (95% CI, 7.3-25).

“This approval is significant because data from our VIALE-A trial has shown that newly-diagnosed patients, who cannot undergo intensive chemotherapy, lived longer when treated with Venclexta plus azacitidine than those treated with azacitidine alone,” said Mohamed Zaki, MD, PhD, vice president and global head of oncology development, AbbVie. “This trial also provides physicians more information for managing patients – from treatment initiation, to assessing response and management post disease remission.”

Venclexta is also indicated for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, in patients how have received at least 1 prior therapy, along or in combination with rituximab. It is available as 10mg, 50mg, and 100mg strength tablets.

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  1. Venclexta® (venetoclax) receives FDA full approval for acute myeloid leukemia (AML). [press release]. North Chicago, IL: AbbVie, Inc; October 16, 2020. 
  2. Venclexta [package insert]. North Chicago, IL; AbbVie, Inc; 2020.

This article originally appeared on MPR