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.
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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07605949 |
Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML |
NOT_YET_RECRUITING | PHASE2 |
| 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 |
