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PMID
Authors
Title Venclexta (venetoclax) FDA Drug Label
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Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208573
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Venetoclax Venetoclax 9 22
Drug Name Trade Name Synonyms Drug Classes Drug Description
Venetoclax Venclexta ABT-199|RG7601|GDC-0199|ABT119 BCL2 inhibitor 18 Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown chronic lymphocytic leukemia not applicable Venetoclax FDA approved Actionable In a Phase II clinical trial, treatment with Venclexta (venetoclax) resulted in an overall response rate of 79.4% in chronic lymphocytic leukemia patients with 17p deletion (PMID: 27014415). detail... 27014415
Unknown unknown acute myeloid leukemia not applicable Azacitidine + Venetoclax FDA approved Actionable In a Phase I/II trial that supported FDA approval, Venclexta (venetoclax) in combination with decitabine or azacitidine resulted in complete remission or complete remission with incomplete count recovery in 65% (40/62) of patients 75 years old or older with treatment-naive acute myeloid leukemia ineligible for intensive chemotherapy, with an overall survival of 11 months (PMID: 30361262; NCT02203773). detail... 30361262
Unknown unknown acute myeloid leukemia not applicable Decitabine + Venetoclax FDA approved Actionable In a Phase I/II trial that supported FDA approval, Venclexta (venetoclax) in combination with decitabine or azacitidine resulted in complete remission or complete remission with incomplete count recovery in 65% (40/62) of patients 75 years old or older with treatment-naive acute myeloid leukemia ineligible for intensive chemotherapy, with an overall survival of 11 months (PMID: 30361262; NCT02203773). detail... 30361262
Unknown unknown CLL/SLL not applicable Obinutuzumab + Venetoclax FDA approved Actionable In a Phase III trial that supported FDA approval (CLL14), treatment with the combination of Venclexta (venetoclax) and Gazyva (obinutuzumab) resulted in improved progression-free survival (PFS) compared to treatment with Gazyva (obinutuzumab) plus chlorambucil ((HR 0.35; 95% CI 0.23-0.53; P<0.0001) (J Clin Oncol 37, 2019 (suppl; abstr 7502; NCT02242942). detail... detail...
Unknown unknown chronic lymphocytic leukemia not applicable Venetoclax FDA approved Actionable In a Phase II trial that supported FDA approval, treatment with Venclexta (venetoclax) resulted in an overall response rate of 65% (59/91), median progression free-survival of 24.7 months, and median duration of response was not reached in chronic lymphocytic leukemia patients who had progressed on prior Zydelig (idelalisib) therapy (PMID: 29305552; NCT02141282). detail... 29305552
Unknown unknown chronic lymphocytic leukemia not applicable Rituximab + Venetoclax FDA approved Actionable In a Phase III trial (MURANO) that supported FDA approval, Venclexta (venetoclax) treatment combined with Rituxan (rituximab) at the beginning of treatment resulted in significantly improved 2-year progression-free survival rate (84.9% vs 36.3%) compared to Treanda (bendamustine) and Rituxan (rituximab) combination in patients with relapsed or refractory chronic lymphocytic leukemia, with (81.5% vs 27.8%) or without (85.9% vs 41.0%) chromosome 17p deletion (PMID: 29562156; NCT02005471). detail... 29562156
Unknown unknown acute myeloid leukemia not applicable Cytarabine + Venetoclax FDA approved Actionable In a Phase I/II trial that supported FDA approval, Venclexta (venetoclax) in combination with low-dose cytarabine resulted in complete remission or complete remission with incomplete count recovery in 54% (44/82) of patients with acute myeloid leukemia who were ineligible for intensive chemotherapy, with a median overall survival of 10 months (ASH Annual Meeting, Dec 2018, Abstract 284; NCT02287233). detail... detail...
Unknown unknown chronic lymphocytic leukemia not applicable Venetoclax FDA approved Actionable In a Phase II trial that supported FDA approval, Venclexta (venetoclax) treatment resulted in an overall response rate of 65% (59/91) and a median follow-up of 14 months in chronic lymphocytic leukemia patients who were refractory to or relapsed on Imbruvica (ibrutinib) therapy (PMID: 29246803; NCT02141282). detail... 29246803