{"entity":{"id":"venetoclax","kind":"drug","name":"Venetoclax","aka":[],"tldr":"A pill that removes the survival shield from leukaemia cells, enabling chemotherapy-free, time-limited treatment for CLL.","summary":"Venetoclax is a BH3-mimetic that selectively inhibits BCL-2, removing the survival shield that lets leukaemia cells ignore apoptotic signals. In CLL it enables chemotherapy-free, time-limited treatment: fixed-duration venetoclax with obinutuzumab (CLL14) or with ibrutinib, following approval in 2016 for CLL with 17p deletion. In AML it is combined with azacitidine, decitabine or low-dose cytarabine for patients unfit for intensive chemotherapy (VIALE-A, approved 2018). AbbVie and Genentech co-develop it, and tumour lysis syndrome is the key early risk, managed with a 5-week ramp-up from 20 to 400 mg daily in CLL and a 3-day ramp in AML. Open questions include MRD-guided treatment duration, use in fit AML patients and resistance through BCL-2 mutations or MCL-1. For a newcomer: a pill that reopens the cell's self-destruct switch.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Venetoclax","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Venetoclax"},{"label":"Blombery et al., Cancer Discov 2019: the recurrent BCL2 Gly101Val mutation confers resistance to venetoclax","url":"https://doi.org/10.1158/2159-8290.CD-18-1119"}],"tags":[],"related":[],"cancers":["cll","aml","aml-older-unfit"],"sections":[],"technologies":["kinase-inhibitors","bcl2-inhibitors"],"targets":["bcl2"],"drugs":[],"companies":["abbvie","roche-genentech"],"institutions":[],"pathways":[],"terms":["lymphoma-bio-antigen-escape"],"trials":["nct03844048","nct03539744","nct03314181","nct04068597","nct05951959","nct07387471","nct06115135","nct04988555","nct02899052","nct06382168","nct05673057","nct07007312","nct06943872","nct04588922","nct05947851","nct02966756","nct07277231","nct06428019","nct06846671","nct04229979","nct04256317","nct07743112","nct05211570","nct07154264","nct04581512","nct05520567","nct04965493","nct07581002","nct07024706","nct04086264","nct05963074","nct05057494","nct04895436","nct07255872","nct07520006","nct06456463","nct06524375"],"people":["peter-hillmen"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Lymphoma biology: the escape mutation is in the drug's own binding groove. BCL2 G101V lowers affinity for venetoclax about 180-fold and was found at progression in 7 of 15 paired patients and in none at study entry, first detectable 19 to 42 months into treatment and months before clinical progression (Blombery 2019). The reason venetoclax has not repeated its chronic lymphocytic leukaemia result in lymphoma is different: those cells lean on MCL1 and BCL-xL as well as on BCL-2."],"brand":"Venclexta","modality":"Small-molecule BCL-2 inhibitor","mechanism":"BH3-mimetic selective BCL-2 inhibitor.","approvals":[{"region":"US","year":2016,"indication":"CLL with 17p deletion"},{"region":"US","year":2018,"indication":"AML with azacitidine/decitabine/LDAC in unfit patients"}],"mechanismSteps":["Venetoclax occupies the BH3-binding groove of BCL-2","Pro-apoptotic BIM and BAX/BAK are released","Mitochondrial outer membrane is permeabilised","Cytochrome c triggers caspase activation","Leukaemic cells die within hours (tumour lysis risk)"],"dosing":{"route":"Oral","schedule":"CLL: 5-week ramp-up 20 → 50 → 100 → 200 → 400 mg daily, then 400 mg daily (fixed 12 months with obinutuzumab); AML: 3-day ramp to 400 mg daily with azacitidine (100 mg with posaconazole)","modifications":"TLS prophylaxis (hydration, allopurinol; hospitalisation for high tumour burden); reduce with CYP3A inhibitors","monitoring":"Chemistry and uric acid at each ramp step; blood counts","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Neutropenia","note":"CLL14: ~53% grade 3-4 with obinutuzumab"},{"event":"Diarrhoea"},{"event":"Nausea"},{"event":"Anaemia"},{"event":"Upper respiratory infection"},{"event":"Tumour lysis syndrome","note":"Prevented by ramp-up; rare with prophylaxis"}],"access":[{"country":"US","reimbursement":"Medicare Part D (oral); commercial plans per formulary, often with prior authorisation","assistance":"https://www.venclexta.com/support","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended in CLL (TA487, TA561, TA663) and AML with azacitidine (TA765)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2016-04-11","type":"accelerated-approval","region":"US","note":"CLL with 17p deletion after ≥1 therapy: first BCL-2 inhibitor","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapy"},{"date":"2018-06-08","type":"conversion","region":"US","note":"CLL/SLL with rituximab (MURANO)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapy"},{"date":"2018-11-21","type":"accelerated-approval","region":"US","note":"Newly diagnosed AML in unfit patients with azacitidine/decitabine/LDAC (accelerated)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"In combination with azacitidine or decitabine or low-dose cytarabine for newly-diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy"},{"date":"2019-05-15","type":"approval","region":"US","note":"First-line CLL with obinutuzumab (CLL14)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-10-16","type":"conversion","region":"US","note":"Full approval in AML (VIALE-A)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"In combination with azacitidine or decitabine or low-dose cytarabine for newly-diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy"}]},"route":"/drugs/venetoclax/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-paediatric","kind":"cancer","name":"Acute myeloid leukaemia in children","route":"/cancers/aml-paediatric/"},{"id":"aml-older-unfit","kind":"cancer","name":"Acute myeloid leukaemia in older or unfit patients","route":"/cancers/aml-older-unfit/"},{"id":"bpdcn","kind":"cancer","name":"Blastic plasmacytoid dendritic cell neoplasm (BPDCN)","route":"/cancers/bpdcn/"},{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"cll-treatment-naive","kind":"cancer","name":"Chronic lymphocytic leukaemia, first 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