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A pill that removes the survival shield from leukaemia cells, enabling chemotherapy-free, time-limited treatment for CLL.
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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
BH3-mimetic selective BCL-2 inhibitor. Connects to BCL-2.
1.Venetoclax occupies the BH3-binding groove of BCL-2
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA663 · SMC advice: venetoclax. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapy
CLL with 17p deletion after ≥1 therapy: first BCL-2 inhibitor source
Chronic lymphocytic leukemia with 17P deletion as detected by an FDA-approved test, after at least one prior therapy
CLL/SLL with rituximab (MURANO) source
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
Newly diagnosed AML in unfit patients with azacitidine/decitabine/LDAC (accelerated) source
First-line CLL with obinutuzumab (CLL14) source
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
Full approval in AML (VIALE-A) source
| Region | Year | Indication |
|---|---|---|
| US | 2016 | CLL with 17p deletion |
| US | 2018 | AML with azacitidine/decitabine/LDAC in unfit patients |
| Adverse event |
|---|
| Neutropenia CLL14: ~53% grade 3-4 with obinutuzumab |
| Diarrhoea |
| Nausea |
| Anaemia |
| Upper respiratory infection |
| Tumour lysis syndrome Prevented by ramp-up; rare with prophylaxis |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | venclexta.com/support |
| United Kingdom | NICE: recommended in CLL (TA487, TA561, TA663) and AML with azacitidine (TA765) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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AMPLIFY delivered the first all-oral, fixed-duration doublet for front-line CLL and supported its approval, giving fit patients a way to avoid both chemotherapy and years of continuous BTK inhibitor. It does not settle whether a doublet or triplet is best, or how AV compares with venetoclax-obinutuzumab. Patients with TP53 aberration were excluded and still need different strategies.
AGILE showed that for the roughly 6-10% of AML patients with an IDH1 mutation, a targeted doublet produces survival in the range of two years, an outcome previously unimaginable in unfit patients. Ivosidenib-azacitidine is approved and is one option alongside venetoclax-azacitidine for these patients. Which regimen, or triplet, is best for IDH1-mutated disease has not been settled by a randomised trial.
VIALE-A turned a palliative regimen into one that produces remission in two-thirds of older AML patients and is now the reference treatment for anyone not fit for intensive chemotherapy. It shifted the field towards lower-intensity targeted combinations and opened the door to adding FLT3, IDH and menin inhibitors to the backbone. Cure remains uncommon and most patients relapse within two years.
CLL14 established the first chemotherapy-free, fixed-duration regimen for front-line CLL and made MRD-guided thinking mainstream in the disease. Patients get a year of treatment and then a treatment-free period rather than indefinite therapy. The choice today is between fixed-duration venetoclax combinations and continuous BTK inhibitors, with no proven survival difference.
MURANO made fixed-duration venetoclax the standard for relapsed CLL and showed that stopping therapy after a deep response is safe for most patients. It also established MRD at end of treatment as a practical guide to who is likely to stay in remission. Retreatment with venetoclax at relapse appears feasible.
Query for this drug: (TITLE:"Venetoclax" OR ABSTRACT:"Venetoclax" OR TITLE:"Venclexta" OR ABSTRACT:"Venclexta") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Venetoclax, not a curated reading list.
Shares Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome, Aptose Biosciences, A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1), Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia.
Shares Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome, Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies, Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL), A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
Shares A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia, SYMPATICO, Fixed-duration vs continuous therapy, Splenic B-cell lymphoma/leukaemia with prominent nucleoli (formerly B-cell prolymphocytic leukaemia and hairy cell leukaemia variant).
Shares A Study of Acalabrutinib Plus Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma, Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab, A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL).
Shares GLOW, CELESTIAL-TNCLL, AMPLIFY, CAPTIVATE.
Shares Caution: chemoimmunotherapy in del(17p)/TP53 CLL, CLL-IPI (chronic lymphocytic leukaemia prognostic index), AMPLIFY, MURANO: two years of venetoclax plus rituximab versus chemo-immunotherapy in relapsed CLL.
Shares Caution: chemoimmunotherapy in del(17p)/TP53 CLL, A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia, CLL-IPI (chronic lymphocytic leukaemia prognostic index), CELESTIAL-TNCLL.
Shares Barbara Eichhorst, John F. Seymour, Kirsten Fischer, Venetoclax + obinutuzumab (12 months).