In April 2016, the U.S. FDA ( Food and Drug Administration ) first granted accelerated approval of Venclexta ( Venetoclax ) for the treatment of patients with chronic lymphocytic leukemia ( CLL ) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.
The FDA approved this indication under accelerated approval based on overall response rate.

Based on the results of the MURANO study, Venclexta was approved in June 2018 for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma ( SLL ), with or without 17p deletion, who have received at least one prior therapy.

In November 2018, Venclexta was approved in combination with Azacitidine, or Decitabine, or low-dose Cytarabine to treat adults with newly-diagnosed acute myeloid leukemia ( AML ) who are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy.

The FDA has approved Venclexta in combination with Obinutuzumab ( Gazyva ) for previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
The FDA granted Breakthrough Therapy designation for this combination therapy, and early submission of the data was provided under the Real-Time Oncology Review ( RTOR ) pilot program, which led to approval in just over two months, following submission of the complete application.

The FDA approval has provided a new chemotherapy-free combination treatment option for patients.
The approval is based on findings from the CLL14 trial in which patients received a 12-month treatment regimen.
The majority of patients receiving Venetoclax in the trial remained progression-free at two years.

The prospective, multicenter, open-label, randomized phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group ( DCLLSG ), evaluated the efficacy and safety of a combined regimen of Venetoclax and Obinutuzumab ( n=216 ) versus Obinutuzumab and Chlorambucil ( n=216 ) in previously untreated patients with CLL and coexisting medical conditions ( total Cumulative Illness Rating Scale [ CIRS ] score more than 6 or creatinine clearance less than 70 mL/min ).
The therapies were administered for a fixed duration of 12 months for Venetoclax in combination with six cycles of Obinutuzumab.
The trial enrolled 432 patients, all of whom were previously untreated according to the International Workshop on Chronic Lymphocytic Leukemia ( iwCLL ) criteria.
Efficacy was based on progression-free survival ( PFS ) as assessed by an Independent Review Committee ( IRC ).
Key secondary endpoints were MRD negativity in peripheral blood and bone marrow, overall and complete response rates, MRD negativity in complete response in peripheral blood and bone marrow, and overall survival.

Venetoclax is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 ( BCL-2 ) protein.
In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis.
Venetoclax targets the BCL-2 protein and works to help restore the process of apoptosis. ( Xagena_2019 )

Source: Abbvie, 2019

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