Also known as: Venclexta, VENCLEXTA
Venetoclax is marketed as VENCLEXTA, an oral BCL-2 inhibitor used in chronic lymphocytic leukemia/small lymphocytic lymphoma and in combination regimens for newly diagnosed acute myeloid leukemia in patients not eligible for intensive induction chemotherapy. U.S. initial approval was in 2016.
MD Anderson researchers developed GT19630, a first-in-class dual-degrader targeting MYC and GSPT1, showing potent preclinical activity in blood cancers including treatment-resistant and TP53-mutated disease. The drug also restored venetoclax sensitivity in resistant AML models.
AbbVie will present new lung cancer data at WCLC 2026, including Phase 1b results for ABBV-1480 showing high response rates in NSCLC and safety updates for ABBV-706 in SCLC. The company also reported progress in dermatology, obesity, and Crohn's disease programs.
New research highlights strategies to overcome cancer drug resistance: a triple-drug AML combination, a breast cancer resistance target, evolutionary treatment switching, DNA damage mechanisms, and sildenafil's anti-metastatic potential.
AbbVie's Q2 2026 revenue hit $16.99 billion, beating estimates, but full-year EPS guidance was cut to $13.97. Growth in immunology and neuroscience continued, and the FAST study on ubrogepant wrapped up.
The FDA has cleared an IND for Amphista's novel BRD9 degrader AMX-883 for AML, approved Lantheus' new prostate cancer imaging agent Pylarify TruVu, and accepted Biofrontera's sNDA for Ameluz PDT in superficial basal cell carcinoma. These regulatory milestones span hematologic and solid tumor areas, addressing significant unmet medical needs.
Two separate clinical trials have reported advances in cancer care. An oral drug combination of decitabine-cedazuridine and venetoclax showed efficacy in older patients with acute myeloid leukemia, with a 47% complete response rate in a phase 2b trial. A separate randomized controlled trial found that delaying pegfilgrastim administration to 72 hours post-chemotherapy significantly reduced bone pain in women with stage I–III breast cancer.
Moleculin Biotech's Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory acute myeloid leukemia reported a preliminary complete remission rate of approximately 30% and composite remission rate exceeding 40% in the first 45 subjects. The blinded data show a substantial improvement over historical rates with cytarabine alone. The trial is expected to reach its first unblinding milestone in mid-2026.
US FDA approved Calquence (acalabrutinib) plus venetoclax as the first all-oral, fixed-duration regimen for adults with chronic lymphocytic leukaemia and small lymphocytic lymphoma. Approval based on AMPLIFY phase III trial showing 77% progression-free at three years vs 67% with chemoimmunotherapy. Regimen already cleared in EU, UK, and Canada.
FDA approves Genentech's Tecentriq as first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, and Venclexta plus acalabrutinib as first all-oral fixed-duration regimen for CLL.
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07773909 |
Venetoclax With Hypomethylating Agents in Newly Diagnosed AML Unfit for Intensive Chemotherapy |
COMPLETED | PHASE4 |
| NCT07762508 |
A Study of VABu Conditioning Regimen in Allo-HSCT for AML Patients |
NOT_YET_RECRUITING | NA |
| NCT07754799 |
A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia |
NOT_YET_RECRUITING | PHASE2 |
| NCT07743112 |
A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia |
RECRUITING | PHASE2 |
| NCT07735117 |
Mitoxantrone Hydrochloride Liposome, Cytarabine, G-CSF Plus Venetoclax vs. Azacitidine Plus Venetoclax for MDS-IB2 and Secondary/Elderly AML |
NOT_YET_RECRUITING | PHASE3 |
| NCT07734038 |
Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07722767 |
A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients |
NOT_YET_RECRUITING | PHASE1 |
| NCT07719556 |
Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL) |
RECRUITING | PHASE2 |
| NCT07713732 |
TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors |
NOT_YET_RECRUITING | PHASE1 |
| NCT07690891 |
Nemtabrutinib With Venetoclax and Obinutuzumab in Patients With Chronic Lymphocytic Leukemia |
NOT_YET_RECRUITING | PHASE2 |
