Also known as: 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.
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.
Moleculin said its MIRACLE Phase 2B/3 AML trial is nearing first unblinding, with blinded CRc above 40% and CR around 30%. The first 45-subject readout is expected before June 30, 2026.
AbbVie raised 2026 revenue and EPS guidance after first-quarter results beat estimates, with Skyrizi and Rinvoq driving growth. Humira erosion continued as neuroscience, oncology and pipeline assets supported the outlook.
Experts discuss balancing efficacy and safety in BTK inhibitor plus venetoclax combination therapy for CLL, including BTK lead-in strategies to reduce tumor lysis syndrome risk and the benefits of all-oral fixed-duration regimens.
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
AbbVie said Skyrizi and Rinvoq generated $26.0 billion in 2025 sales and are expected to exceed $31 billion in 2026. The company said the two immunology drugs continue to offset Humira erosion and drive top-line growth.
The FDA approved acalabrutinib plus venetoclax for previously untreated CLL/SLL based on phase 3 AMPLIFY data. The fixed 14-month regimen improved progression-free survival versus chemotherapy.
The phase 3 AMPLIFY trial in frontline chronic lymphocytic leukemia showed improved efficacy with acalabrutinib plus venetoclax versus standard of care. The source text identified the study as NCT03836261.
Omeros reported initial nonhuman primate data for OncotoX-AML in acute myeloid leukemia. One treatment course reduced myeloid progenitor cells by up to 99% and was well tolerated.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07604233 |
Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07582159 |
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07581002 |
A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07557056 |
Nemtabrutinib and Venetoclax for the Treatment of Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07539818 |
Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML |
NOT_YET_RECRUITING | PHASE3 |
| NCT07520006 |
Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07513129 |
Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma |
NOT_YET_RECRUITING | PHASE1 |
| NCT07511062 |
Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML |
NOT_YET_RECRUITING | PHASE1 |
| NCT07495631 |
Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia |
RECRUITING | NA |
| NCT07493161 |
Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL |
RECRUITING | NA |
