Venetoclax
A pill that removes the survival shield from leukaemia cells, enabling chemotherapy-free, time-limited treatment for CLL.
CLL (fixed-duration with obinutuzumab, CLL14; with ibrutinib), AML with azacitidine in unfit patients (VIALE-A). AbbVie/Genentech. Tumour lysis syndrome managed by ramp-up dosing.
1.Venetoclax occupies the BH3-binding groove of BCL-2
- 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)
- Dose 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: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- myAbbVie Assist
- Genentech Access Solutions
- Genentech Patient Foundation — Free medicine for eligible patients regardless of insurance type.
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Appraised for
- With obinutuzumab for untreated CLL
- Notes
- Monotherapy for 17p/TP53 CLL: TA487 (2017, CDF). With rituximab for relapsed CLL: TA561 (2019). With azacitidine or low-dose cytarabine for AML unsuitable for intensive chemotherapy: TA765 (2022). Fixed-duration venetoclax-ibrutinib appraised 2024-25.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA663 · SMC advice: venetoclax. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 11 Apr 2016ApprovalUS
CLL with 17p deletion after ≥1 therapy: first BCL-2 inhibitor source
- 8 Jun 2018ApprovalUS
CLL/SLL with rituximab (MURANO) source
- 21 Nov 2018ApprovalUS
Newly diagnosed AML in unfit patients with azacitidine/decitabine/LDAC (accelerated) source
- 15 May 2019ApprovalUS
First-line CLL with obinutuzumab (CLL14) source
- 16 Oct 2020ApprovalUS
Full approval in AML (VIALE-A) source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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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.
Latest papers
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